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Duloxetine in Patients With Diabetic in Peripheral Neuropathic Pain With or Without Co-morbid Major Depressive Disorder

Primary Purpose

Diabetic Neuropathies, Depressive Disorder, Major

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Duloxetine 60 mg QD

Duloxetine 30 mg QD

Duloxetine 90 mg QD

Duloxetine 60 mg QD

Duloxetine 120 mg QD

Duloxetine 30 mg QD

Duloxetine 120 mg QD

About this trial

This is an interventional treatment trial for Diabetic Neuropathies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10).
To qualify for the MDD+ cohort, patients need to meet the ICD-10 criteria for MDD. Furthermore, Hamilton rating scale for depression 17 (HAMD-17) scores need to match with the ICD-10 criteria for qualification of the MDD+ or MDD- groups.
Male or female outpatients at least 18 years of age.
Females with child bearing potential must test negative for a serum pregnancy test at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Clinovir Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study.
Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator.
Judged to be reliable and agrees to keep all appointments for clinic visits, tests, and procedures required by the protocol.

Exclusion criteria:

Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study.
Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain.
Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy.
Have previously been treated with duloxetine (for DPNP or MDD)
Are judged to be at suicidal risk by the clinical investigator or as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II).
Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Arm Label

DPNP with depression (1)

DPNP with depression (2)

DPNP without depression (1)

DPNP without depression (2)

Arm Description

Patients that have diabetic polyneuropathy and depression and are responder to 60 mg duloxetine QD (>30% pain reduction after week 6)

Patients that have diabetic polyneuropathy and depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6)

Patients that have diabetic polyneuropathy and no depression and are responder to 60 mg duloxetine QD (>30% pain reduction after week 6)

Patients that have diabetic polyneuropathy and no depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6)

Outcomes

Primary Outcome Measures

Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Secondary Outcome Measures

Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in BPI Worst Pain During Treatment From Baseline to Week 2

The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Change in Worst Pain (BPI) From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Change in Worst Pain (BPI) From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Change in Least Pain (BPI) From Baseline to Week 2

The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Change in Least Pain During Treatment (BPI) From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Change in Least Pain (BPI) From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Change in Average Pain (BPI) From Baseline to Week 2

The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Change in Average Pain During Treatment (BPI) From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Change in Average Pain (BPI) From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Number of Patients With a Reduction in BPI Average Pain at Week 2

Number of Patients With a Reduction in BPI Average Pain at Week 6

Number of Patients With a Reduction in BPI Average Pain at Week 12

Change in Pain During Treatment (BPI) From Baseline to Week 2

The change from baseline reflects the pain at week 2 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Change in Pain (BPI) From Baseline to Week 6

The change from baseline reflects the pain at week 6 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Change in Pain During Treatment (BPI) From Baseline to Week 12

The change from baseline reflects the pain at week 12 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2

The change from baseline reflects the week 2 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).

Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6

The change from baseline reflects the week 6 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).

Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12

The change from baseline reflects the week 12 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).

Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Mood (BPI) From Baseline to Week 2

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Mood (BPI) From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Mood (BPI) From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Patient Global Impression - Improvement (PGI-I) at Week 2

The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).

Patient Global Impression - Improvement (PGI-I) at Week 6

The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).

Patient Global Impression - Improvement (PGI-I) at Week 12

The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).

Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2

The change from baseline reflects the week 2 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.

Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.

Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.

Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2

The change from baseline reflects the week 2 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).

Change in HADS Anxiety Total Score From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).

Change in HADS Anxiety Total Score From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).

Change in HADS Depression Total Score From Baseline to Week 2

The change from baseline reflects the week 2 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).

Change in HADS Depression Total Score From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).

Change in HADS Depression Total Score From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).

Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.

Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.

Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.

Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.

Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6

Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).

Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12

Pain-related life interference (with family and marital functioning, work, social activities). The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no interference) to 6 (extreme interference).

Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6

Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).

Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12

Appraisal of support received from spouse, family and significant others. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no support) to 6 (very much support).

Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (not at all strong) to 6 (very strong).

Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).

Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6

Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).

Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12

Perceived life control and ability to solve problems and feelings of personal mastery and competence. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).

Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6

Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).

Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12

Affective distress, including ratings of depressed mood, irritability, and tension. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no distress) to 6 (extreme distress).

Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6

Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12

Degree to which significant others display negative responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6

Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12

Degree to which significant others display solicitous responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 6

Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 12

Degree to which significant others display distracting responses to the patient's pain behaviors and complaints. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6

Frequency with which the patient engages in household chores. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12

Frequency with which the patient engages in household chores. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6

Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12

Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6

Frequency with which the patient engages in social activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12

Frequency with which the patient engages in social activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6

Frequency with which the patient engages in general activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12

Frequency with which the patient engages in general activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Change in Clinical Global Impression - Severity Pain From Baseline to Week 2

The change from baseline reflects the week 2 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).

Change in Clinical Global Impression - Severity Pain From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).

Change in Clinical Global Impression - Severity Pain From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).

Change in Hamilton Depression Score From Baseline to Week 2

The change from baseline reflects the week 2 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.

Change in Hamilton Depression Score From Baseline to Week 6

The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.

Change in Hamilton Depression Score From Baseline to Week 12

The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.

Suicidal Thoughts by BDI-II at Week 2

Suicidal Thoughts by BDI-II at Week 6

Suicidal Thoughts by BDI-II at Week 12

Suicidal Thoughts or Behaviours by HAMD-17 at Week 2

Suicidal Thoughts or Behaviours by HAMD-17 at Week 6

Suicidal Thoughts or Behaviours by HAMD-17 at Week 12

Change of Fasting Blood Glucose From Baseline at Week 12

Ancova analysis controlling for baseline and insulin intake

Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12

Ancova analysis controlling for baseline and insulin intake

Change of Systolic Blood Pressure From Baseline at Week 12

Change of Diastolic Blood Pressure From Baseline at Week 12

Change of Pulse Rate From Baseline at Week 12

Full Information

NCT ID

NCT00844194

First Posted

February 13, 2009

Last Updated

May 2, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00844194

Brief Title

Duloxetine in Patients With Diabetic in Peripheral Neuropathic Pain With or Without Co-morbid Major Depressive Disorder

Official Title

A 12 Weeks Open Label Two Parallel Groups Study to Assess the Efficacy of Orally Administered Duloxetine 60 mg and 120 mg Per Day on Treatment Outcomes in Patients With Diabetic Peripheral Neuropathic Pain With and Without Co-morbid Major Depressive Disorder. The Primary Objective of This Study is to Evaluate Whether the Efficacy of Duloxetine Given as 60 mg to 120 mg Once Daily (QD), Measured by the BPI Interference Score After 12 Weeks Shows a Clinically Relevant Improvement in the DPNP Patients With Co-morbid MDD

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

The primary objective is to evaluate, separately in diabetic polyneuropathic pain (DPNP) patients with and without co-morbid major depressive disorder (MDD), whether duloxetine given as 60 mg to 120 mg once daily (QD) leads to a clinically relevant improvement as measured by the change in Brief Pain Inventory (BPI) 24 hours average interference score from baseline to after 12 weeks. A clinically relevant improvement will be demonstrated if the confidence interval for the mean change from baseline does not lie above the clinically relevant change of -1.35. If statistically significant results are obtained for the DPNP patients with MDD, then the same evaluation will be performed for the DPNP patients without MDD in another confirmatory analysis. As secondary objectives the study will compare the two groups (MDD+/MDD-) regarding efficacy of duloxetine on BPI severity scales, the distribution of different percentages of pain reduction among the patient population, and the patients and physicians impressions of severity and improvement of pain. The study will also compare treatment outcomes regarding patient-relevant functionality and quality of life (QoL) between the two groups (MDD+/MDD-) by evaluating each single BPI interference item, the Short Form 12 (SF-12) Health Questionnaire and the West Haven Multidimensional Pain Inventory (MPI). As a third group of secondary objectives the efficacy of duloxetine of the psychological symptoms (e.g. depression) of DPNP patients with or without depression will be assessed using the Hamilton depression scale, the Beck Depression Inventory-II and the hospital Anxiety and Depression Scale. Further the effect of duloxetine treatment on fasting blood glucose (FBG) and hemoglobin A1c (HbA1c) will be evaluated. To monitor safety and tolerability, treatment discontinuation rates, treatment emergent adverse events, change in vital signs, laboratory results and suicidal thoughts will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Neuropathies, Depressive Disorder, Major

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DPNP with depression (1)

Arm Type

Other

Arm Description

Patients that have diabetic polyneuropathy and depression and are responder to 60 mg duloxetine QD (>30% pain reduction after week 6)

Arm Title

DPNP with depression (2)

Arm Type

Other

Arm Description

Patients that have diabetic polyneuropathy and depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6)

Arm Title

DPNP without depression (1)

Arm Type

Other

Arm Description

Patients that have diabetic polyneuropathy and no depression and are responder to 60 mg duloxetine QD (>30% pain reduction after week 6)

Arm Title

DPNP without depression (2)

Arm Type

Other

Arm Description

Patients that have diabetic polyneuropathy and no depression and are non-responder to 60 mg duloxetine QD (<30% pain reduction after week 6)

Intervention Type

Drug

Intervention Name(s)

Duloxetine 60 mg QD

Intervention Description

given to (1) all patients week 2-6; (2) all responders of both arms week 7-12

Intervention Type

Drug

Intervention Name(s)

Duloxetine 60 mg QD

Intervention Description

given to (1) all patients week 2-6; (2) all responders of both arms week 7-12

Intervention Type

Drug

Intervention Name(s)

Duloxetine 30 mg QD

Intervention Description

given to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks)

Intervention Type

Drug

Intervention Name(s)

Duloxetine 30 mg QD

Intervention Description

given to (1) all patients for one week as taper in; (2) all patients for taper down (responder for 2 weeks)

Intervention Type

Drug

Intervention Name(s)

Duloxetine 90 mg QD

Intervention Description

given to non-responders of both arms from day of notice that 120 mg is not tolerated to week 12 as 60 mg+30 mg Duloxetine QD

Intervention Type

Drug

Intervention Name(s)

Duloxetine 90 mg QD

Intervention Description

given to non-responders of both arms from day of notice that 120 mg is not tolerated to week 12 as 60 mg+30 mg Duloxetine QD

Intervention Type

Drug

Intervention Name(s)

Duloxetine 60 mg QD

Intervention Description

given to (1) all patients week 2-6; (2) all non-responders of both arms for first week of taper down

Intervention Type

Drug

Intervention Name(s)

Duloxetine 60 mg QD

Intervention Description

given to (1) all patients week 2-6; (2) all non-responders of both arms for first week of taper down

Intervention Type

Drug

Intervention Name(s)

Duloxetine 120 mg QD

Intervention Description

given to non-responders of both arms from week 7-12 as 2x60 mg Duloxetine QD, if tolerated

Intervention Type

Drug

Intervention Name(s)

Duloxetine 30 mg QD

Intervention Description

given to (1) all patients for one week as taper in; (2) all patients for taper down (non-responder for the second week of taper down)

Intervention Type

Drug

Intervention Name(s)

Duloxetine 30 mg QD

Intervention Description

given to (1) all patients for one week as taper in; (2) all patients for taper down (non-responder for the second week of taper down)

Intervention Type

Drug

Intervention Name(s)

Duloxetine 120 mg QD

Intervention Description

given to non-responders of both arms from week 7-12 as 2x60 mg Duloxetine QD, if tolerated

Primary Outcome Measure Information:

Title

Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 12

Secondary Outcome Measure Information:

Title

Change of Brief Pain Inventory (BPI) Average Interference Score From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The BPI average interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 6

Title

Change in BPI Worst Pain During Treatment From Baseline to Week 2

Description

The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Time Frame

Baseline and Week 2

Title

Change in Worst Pain (BPI) From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Time Frame

Baseline and Week 6

Title

Change in Worst Pain (BPI) From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Time Frame

Baseline and Week 12

Title

Change in Least Pain (BPI) From Baseline to Week 2

Description

The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Time Frame

Baseline and Week 2

Title

Change in Least Pain During Treatment (BPI) From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Time Frame

Baseline and Week 6

Title

Change in Least Pain (BPI) From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Time Frame

Baseline and Week 12

Title

Change in Average Pain (BPI) From Baseline to Week 2

Description

The change from baseline reflects the week 2 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Time Frame

Baseline and Week 2

Title

Change in Average Pain During Treatment (BPI) From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Time Frame

Baseline and Week 6

Title

Change in Average Pain (BPI) From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Time Frame

Baseline and Week 12

Title

Number of Patients With a Reduction in BPI Average Pain at Week 2

Time Frame

Baseline and Week 2

Title

Number of Patients With a Reduction in BPI Average Pain at Week 6

Time Frame

Baseline and Week 6

Title

Number of Patients With a Reduction in BPI Average Pain at Week 12

Time Frame

Baseline and Week 12

Title

Change in Pain During Treatment (BPI) From Baseline to Week 2

Description

The change from baseline reflects the pain at week 2 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Time Frame

Baseline and Week 2

Title

Change in Pain (BPI) From Baseline to Week 6

Description

The change from baseline reflects the pain at week 6 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Time Frame

Baseline and Week 6

Title

Change in Pain During Treatment (BPI) From Baseline to Week 12

Description

The change from baseline reflects the pain at week 12 minus the pain at baseline. The BPI pain ranges from 0 (no pain) to 10 (pain as bad as the patient can imagine).

Time Frame

Baseline and Week 12

Title

Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 2

Description

The change from baseline reflects the week 2 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).

Time Frame

Baseline and Week 2

Title

Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).

Time Frame

Baseline and Week 6

Title

Change in Relief of Pain (BPI) From the Week Before Baseline to the Week Before Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The relief of pain ranges from 0% (no relief) to 100% (complete relief).

Time Frame

Baseline and Week 12

Title

Change in Interference of Pain With General Activity (BPI) From Baseline to Week 2

Description

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 2

Title

Change in Interference of Pain With General Activity (BPI) From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 6

Title

Change in Interference of Pain With General Activity (BPI) From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 12

Title

Change in Interference of Pain With Mood (BPI) From Baseline to Week 2

Description

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 2

Title

Change in Interference of Pain With Mood (BPI) From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 6

Title

Change in Interference of Pain With Mood (BPI) From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 12

Title

Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 2

Description

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 2

Title

Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 6

Title

Change in Interference of Pain With Walking Ability (BPI) From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 12

Title

Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 2

Description

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 2

Title

Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 6

Title

Change in Interference of Pain With Normal Work (BPI) From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 12

Title

Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 2

Description

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 2

Title

Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 6

Title

Change in Interference of Pain With Relations to Other People (BPI) From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 12

Title

Change in Interference of Pain With Sleep (BPI) From Baseline to Week 2

Description

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 2

Title

Change in Interference of Pain With Sleep (BPI) From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 6

Title

Change in Interference of Pain With Sleep (BPI) From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 12

Title

Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 2

Description

The change from baseline reflects the week 2 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 2

Title

Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 6

Title

Change in Interference of Pain With Enjoyment of Life (BPI) From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The BPI interference score ranges from 0 (pain does not interfere) to 10 (pain completely interferes).

Time Frame

Baseline and Week 12

Title

Patient Global Impression - Improvement (PGI-I) at Week 2

Description

The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).

Time Frame

Baseline and Week 2

Title

Patient Global Impression - Improvement (PGI-I) at Week 6

Description

The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).

Time Frame

Baseline and Week 6

Title

Patient Global Impression - Improvement (PGI-I) at Week 12

Description

The investigator judged the improvement of the patient's global impression during treatment. The score ranges from 1 (very much better) to 7 (very much worse).

Time Frame

Baseline and Week 12

Title

Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 2

Description

The change from baseline reflects the week 2 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.

Time Frame

Baseline and Week 2

Title

Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.

Time Frame

Baseline and Week 6

Title

Change in Beck Depression Inventory Total Score (BDI-II) From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression.

Time Frame

Baseline and Week 12

Title

Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Total Score From Baseline to Week 2

Description

The change from baseline reflects the week 2 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).

Time Frame

Baseline and Week 2

Title

Change in HADS Anxiety Total Score From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).

Time Frame

Baseline and Week 6

Title

Change in HADS Anxiety Total Score From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The HADS anxiety total score ranges from 0 (no anxiety) to 21 (extreme anxiety).

Time Frame

Baseline and Week 12

Title

Change in HADS Depression Total Score From Baseline to Week 2

Description

The change from baseline reflects the week 2 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).

Time Frame

Baseline and Week 2

Title

Change in HADS Depression Total Score From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).

Time Frame

Baseline and Week 6

Title

Change in HADS Depression Total Score From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The HADS depression total score ranges from 0 (no depression) to 21 (extreme depression).

Time Frame

Baseline and Week 12

Title

Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.

Time Frame

Baseline and Week 6

Title

Change in Short Form Health Survey (SF-12) - Physical Component Summary From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of physical health. Values can range from 0 to 100.

Time Frame

Baseline and Week 12

Title

Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.

Time Frame

Baseline and Week 6

Title

Change in Short Form Health Survey (SF-12) - Mental Component Summary From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of mental health. Values can range from 0 to 100.

Time Frame

Baseline and Week 12

Title

Change in Multidimensional Pain Inventory (MPI): Interference of Pain (With Subjective Well-being) From Baseline to Week 6

Description

Time Frame

Baseline and Week 6

Title

Change in Multidimensional Pain Inventory (MPI): Interference of Pain From Baseline to Week 12

Description

Time Frame

Baseline and Week 12

Title

Change in Multidimensional Pain Inventory (MPI): Support From Baseline to Week 6

Description

Time Frame

Baseline and Week 6

Title

Change in Multidimensional Pain Inventory (MPI): Support Which the Patient Received From Baseline to Week 12

Description

Time Frame

Baseline and Week 12

Title

Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (not at all strong) to 6 (very strong).

Time Frame

Baseline and Week 6

Title

Change in Multidimensional Pain Inventory (MPI): Pain Severity From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (no control) to 6 (extreme control).

Time Frame

Baseline and Week 12

Title

Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 6

Description

Time Frame

Baseline and Week 6

Title

Change in Multidimensional Pain Inventory (MPI): Life Control From Baseline to Week 12

Description

Time Frame

Baseline and Week 12

Title

Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 6

Description

Time Frame

Baseline and Week 6

Title

Change in Multidimensional Pain Inventory (MPI): Affective Distress From Baseline to Week 12

Description

Time Frame

Baseline and Week 12

Title

Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 6

Description

Time Frame

Baseline and Week 6

Title

Change in Multidimensional Pain Inventory (MPI): Negative Responses From Baseline to Week 12

Description

Time Frame

Baseline and Week 12

Title

Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 6

Description

Time Frame

Baseline and Week 6

Title

Change in Multidimensional Pain Inventory (MPI): Solicitous Responses From Baseline to Week 12

Description

Time Frame

Baseline and Week 12

Title

Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 6

Description

Time Frame

Baseline and Week 6

Title

Change in Multidimensional Pain Inventory (MPI): Degree to Which Significant Others Display Distracting Responses to the Patient's Pain Behaviors and Complaints From Baseline to Week 12

Description

Time Frame

Baseline and Week 12

Title

Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 6

Description

Frequency with which the patient engages in household chores. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Time Frame

Baseline and Week 6

Title

Change in Multidimensional Pain Inventory (MPI): Household Chores From Baseline to Week 12

Description

Frequency with which the patient engages in household chores. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Time Frame

Baseline and Week 12

Title

Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 6

Description

Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Time Frame

Baseline and Week 6

Title

Change in Multidimensional Pain Inventory (MPI): Outdoor Work From Baseline to Week 12

Description

Frequency with which the patient engages in outdoor work. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Time Frame

Baseline and Week 12

Title

Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 6

Description

Frequency with which the patient engages in social activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Time Frame

Baseline and Week 6

Title

Change in Multidimensional Pain Inventory (MPI): Social Activities From Baseline to Week 12

Description

Frequency with which the patient engages in social activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Time Frame

Baseline and Week 12

Title

Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 6

Description

Frequency with which the patient engages in general activities. The change from baseline reflects the week 6 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Time Frame

Baseline and Week 6

Title

Change in Multidimensional Pain Inventory (MPI): General Activities From Baseline to Week 12

Description

Frequency with which the patient engages in general activities. The change from baseline reflects the week 12 value minus the baseline value. The scores range from 0 (never) to 6 (very frequently).

Time Frame

Baseline and Week 12

Title

Change in Clinical Global Impression - Severity Pain From Baseline to Week 2

Description

The change from baseline reflects the week 2 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).

Time Frame

Baseline and Week 2

Title

Change in Clinical Global Impression - Severity Pain From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).

Time Frame

Baseline and Week 6

Title

Change in Clinical Global Impression - Severity Pain From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. The score of the Clinical global impression ranges from 1 (not ill at all) to 7 (extremely ill).

Time Frame

Baseline and Week 12

Title

Change in Hamilton Depression Score From Baseline to Week 2

Description

The change from baseline reflects the week 2 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.

Time Frame

Baseline and Week 2

Title

Change in Hamilton Depression Score From Baseline to Week 6

Description

The change from baseline reflects the week 6 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.

Time Frame

Baseline and Week 6

Title

Change in Hamilton Depression Score From Baseline to Week 12

Description

The change from baseline reflects the week 12 value minus the baseline value. A lower score corresponds to a lower level of depression. The score ranges from 0 to 52.

Time Frame

Baseline and Week 12

Title

Suicidal Thoughts by BDI-II at Week 2

Time Frame

Week 2

Title

Suicidal Thoughts by BDI-II at Week 6

Time Frame

Week 6

Title

Suicidal Thoughts by BDI-II at Week 12

Time Frame

Week 12

Title

Suicidal Thoughts or Behaviours by HAMD-17 at Week 2

Time Frame

Week 2

Title

Suicidal Thoughts or Behaviours by HAMD-17 at Week 6

Time Frame

Week 6

Title

Suicidal Thoughts or Behaviours by HAMD-17 at Week 12

Time Frame

Week 12

Title

Change of Fasting Blood Glucose From Baseline at Week 12

Description

Ancova analysis controlling for baseline and insulin intake

Time Frame

Baseline and Week 12

Title

Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline at Week 12

Description

Ancova analysis controlling for baseline and insulin intake

Time Frame

Baseline and Week 12

Title

Change of Systolic Blood Pressure From Baseline at Week 12

Time Frame

Baseline and Week 12

Title

Change of Diastolic Blood Pressure From Baseline at Week 12

Time Frame

Baseline and Week 12

Title

Change of Pulse Rate From Baseline at Week 12

Time Frame

Baseline and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10). To qualify for the MDD+ cohort, patients need to meet the ICD-10 criteria for MDD. Furthermore, Hamilton rating scale for depression 17 (HAMD-17) scores need to match with the ICD-10 criteria for qualification of the MDD+ or MDD- groups. Male or female outpatients at least 18 years of age. Females with child bearing potential must test negative for a serum pregnancy test at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Clinovir Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study. Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator. Judged to be reliable and agrees to keep all appointments for clinic visits, tests, and procedures required by the protocol. Exclusion criteria: Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study. Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain. Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy. Have previously been treated with duloxetine (for DPNP or MDD) Are judged to be at suicidal risk by the clinical investigator or as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II). Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

1208.34.49008 Boehringer Ingelheim Investigational Site

City

Achim bei Bremen

Country

Germany

Facility Name

1208.34.49025 Boehringer Ingelheim Investigational Site

City

Aschaffenburg

Country

Germany

Facility Name

1208.34.49001 Boehringer Ingelheim Investigational Site

City

Bad Mergentheim

Country

Germany

Facility Name

1208.34.49018 Boehringer Ingelheim Investigational Site

City

Baesweiler

Country

Germany

Facility Name

1208.34.49007 Boehringer Ingelheim Investigational Site

City

Berlin-Steglitz

Country

Germany

Facility Name

1208.34.49002 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1208.34.49005 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1208.34.49009 Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

1208.34.49021 Boehringer Ingelheim Investigational Site

City

Bremen

Country

Germany

Facility Name

1208.34.49028 Boehringer Ingelheim Investigational Site

City

Frankfurt am Main

Country

Germany

Facility Name

1208.34.49012 Boehringer Ingelheim Investigational Site

City

Gera

Country

Germany

Facility Name

1208.34.49004 Boehringer Ingelheim Investigational Site

City

Hamburg

Country

Germany

Facility Name

1208.34.49020 Boehringer Ingelheim Investigational Site

City

Hamburg

Country

Germany

Facility Name

1208.34.49023 Boehringer Ingelheim Investigational Site

City

Hamburg

Country

Germany

Facility Name

1208.34.49015 Boehringer Ingelheim Investigational Site

City

Hattingen

Country

Germany

Facility Name

1208.34.49027 Boehringer Ingelheim Investigational Site

City

Heidenheim

Country

Germany

Facility Name

1208.34.49016 Boehringer Ingelheim Investigational Site

City

Kelkheim

Country

Germany

Facility Name

1208.34.49006 Boehringer Ingelheim Investigational Site

City

Limburgerhof

Country

Germany

Facility Name

1208.34.49022 Boehringer Ingelheim Investigational Site

City

Münster

Country

Germany

Facility Name

1208.34.49019 Boehringer Ingelheim Investigational Site

City

Neuwied

Country

Germany

Facility Name

1208.34.49024 Boehringer Ingelheim Investigational Site

City

St. Ingberg

Country

Germany

Facility Name

1208.34.49010 Boehringer Ingelheim Investigational Site

City

Stuhr

Country

Germany

Facility Name

1208.34.49013 Boehringer Ingelheim Investigational Site

City

Unterhaching

Country

Germany

Facility Name

1208.34.49029 Boehringer Ingelheim Investigational Site

City

Wiesbaden

Country

Germany

Facility Name

1208.34.49026 Boehringer Ingelheim Investigational Site

City

Wuppertal

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1208/1208.34_U11-1226.pdf

Description

Related Info

Learn more about this trial

Duloxetine in Patients With Diabetic in Peripheral Neuropathic Pain With or Without Co-morbid Major Depressive Disorder

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Duloxetine in Patients With Diabetic in Peripheral Neuropathic Pain With or Without Co-morbid Major Depressive Disorder

Diabetic Neuropathies, Depressive Disorder, Major

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial