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A Study of Single Dose Pain Therapy in Patients With Painful Diabetic Neuropathy (0000-115)

Primary Purpose

Painful Diabetic Neuropathy

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Comparator: A: Pregabalin

Comparator: B: Duloxetine

Comparator: C: Diphenhydramine hydrochloride

About this trial

This is an interventional treatment trial for Painful Diabetic Neuropathy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient has been treated for type 1 or 2 diabetes mellitus with glycosylated hemoglobin
Patient has pain in both feet that occurred after onset of diabetes
Patient agrees to maintain a consistent activity level throughout the study
Patient is not on chronic pain therapy, or is on a stable dose of one pain therapy
Female patients of reproductive potential must agree to use two acceptable methods of birth control through out the study
Patients taking a pain medication must be on a stable dose at least 1 month prior to participating in study

Exclusion Criteria:

Patient has a history of congestive heart failure
Patient has/had a seizure disorder
Patient has tried and failed 3 or more drugs to treat neuropathic pain
Patient is currently taking pregabalin or duloxetine hydrochloride
Patient has had a malignancy within the past 2 years (excluding basal cell carcinoma)
Patient has history of hepatitis B or C or HIV infection
Patient has skin-condition that may decrease sensitivity in area of neuropathic pain

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Arm Description

sequence 1 - Pregabalin, Duloxetine hydrochloride, Diphenhydramine hydrochloride

sequence 2 - Duloxetine hydrochloride, Pregabalin, Diphenhydramine hydrochloride

sequence 3 - Diphenhydramine hydrochloride, Duloxetine hydrochloride, Pregabalin

sequence 4 - Pregabalin, Diphenhydramine hydrochloride, Duloxetine hydrochloride

sequence 5 - Duloxetine hydrochloride, Diphenhydramine hydrochloride, Pregabalin

sequence 6 - Diphenhydramine hydrochloride, Pregabalin, Duloxetine hydrochloride

Outcomes

Primary Outcome Measures

analgesic efficacy measured by patients self reported pain level after single dose administration

Secondary Outcome Measures

The onset of analgesic efficacy following single dose of pregabalin and duloxetine hydrochloride versus placebo

Full Information

NCT ID

NCT00837941

First Posted

February 5, 2009

Last Updated

July 24, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00837941

Brief Title

A Study of Single Dose Pain Therapy in Patients With Painful Diabetic Neuropathy (0000-115)

Official Title

Qualification of Single Dose Administration of Analgesic Therapy in the Treatment of Chronic Neuropathic Pain in Patients With Painful Diabetic Neuropathy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Withdrawn

Study Start Date

April 2009 (undefined)

Primary Completion Date

August 2009 (Anticipated)

Study Completion Date

September 2009 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine if analgesic efficacy can be detected with single dose administration in patients with chronic neuropathic pain due to painful diabetic neuropathy.

6. Conditions and Keywords

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

Painful Diabetic Neuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

sequence 1 - Pregabalin, Duloxetine hydrochloride, Diphenhydramine hydrochloride

Arm Title

Arm Type

Experimental

Arm Description

sequence 2 - Duloxetine hydrochloride, Pregabalin, Diphenhydramine hydrochloride

Arm Title

Arm Type

Experimental

Arm Description

sequence 3 - Diphenhydramine hydrochloride, Duloxetine hydrochloride, Pregabalin

Arm Title

Arm Type

Experimental

Arm Description

sequence 4 - Pregabalin, Diphenhydramine hydrochloride, Duloxetine hydrochloride

Arm Title

Arm Type

Experimental

Arm Description

sequence 5 - Duloxetine hydrochloride, Diphenhydramine hydrochloride, Pregabalin

Arm Title

Arm Type

Experimental

Arm Description

sequence 6 - Diphenhydramine hydrochloride, Pregabalin, Duloxetine hydrochloride

Intervention Type

Drug

Intervention Name(s)

Comparator: A: Pregabalin

Intervention Description

1 Pregabalin 300 mg capsule

Intervention Type

Drug

Intervention Name(s)

Comparator: B: Duloxetine

Intervention Description

1 Duloxetine hydrochloride 60 mg capsule

Intervention Type

Drug

Intervention Name(s)

Comparator: C: Diphenhydramine hydrochloride

Intervention Description

1 Diphenhydramine hydrochloride 25mg capsule

Primary Outcome Measure Information:

Title

analgesic efficacy measured by patients self reported pain level after single dose administration

Time Frame

5-11 hours after single dose is administered

Secondary Outcome Measure Information:

Title

The onset of analgesic efficacy following single dose of pregabalin and duloxetine hydrochloride versus placebo

Time Frame

24 hours after single dose is administered

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient has been treated for type 1 or 2 diabetes mellitus with glycosylated hemoglobin Patient has pain in both feet that occurred after onset of diabetes Patient agrees to maintain a consistent activity level throughout the study Patient is not on chronic pain therapy, or is on a stable dose of one pain therapy Female patients of reproductive potential must agree to use two acceptable methods of birth control through out the study Patients taking a pain medication must be on a stable dose at least 1 month prior to participating in study Exclusion Criteria: Patient has a history of congestive heart failure Patient has/had a seizure disorder Patient has tried and failed 3 or more drugs to treat neuropathic pain Patient is currently taking pregabalin or duloxetine hydrochloride Patient has had a malignancy within the past 2 years (excluding basal cell carcinoma) Patient has history of hepatitis B or C or HIV infection Patient has skin-condition that may decrease sensitivity in area of neuropathic pain

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

A Study of Single Dose Pain Therapy in Patients With Painful Diabetic Neuropathy (0000-115)

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