search
Back to results

An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain

Primary Purpose

Back Pain Lower Back Chronic

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain Lower Back Chronic focused on measuring Chronic Low Back Pain, CLBP

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(Consecutive Participants):

  • Participants who have completed the 15-week administration in the phase 3 clinical study of Duloxetine hydrochloride in participants with CLBP, study HMGY (NCT01855919)
  • Female participants having child-bearing potential must test negative (-) on a pregnancy test

(New Participants):

  • Participants with CLBP present for the preceding 6 months or longer
  • Participants used nonsteroidal anti-inflammatory drugs for CLBP for less than 14 days on average per month in the past 3 months and less than 14 days in one month prior to study
  • Participants having a score of ≥4 on Brief Pain Inventory (BPI) average pain score at participation of study
  • Female participants having child-bearing potential must test negative (-) on a pregnancy test

Exclusion Criteria:

(Consecutive Participants):

  • Participants having serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychiatric conditions that, in the opinion of investigator, would compromise participation or be likely to lead to hospitalization during the course of the study
  • Participants having alanine aminotransferase or aspartate aminotransferase higher than 100 International Units per Liter (IU/L) or total bilirubin higher than 1.6 milligram per deciliter (mg/dL)
  • Participants having serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or receiving renal dialysis
  • Participants having diagnosis seronegative spondyloarthropathy or rheumatoid arthritis
  • Participants having primary painful condition due to other than CLBP
  • Participants having uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension
  • Participants treating with a monoamine oxidase inhibitor (MAOI) within 14 days or the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug
  • Participants answering "yes" to any of the questions about active suicidal ideation/intent/behaviors occurring within the past month (Columbia Suicide Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section)
  • Pregnant participants or participants who are breast-feeding, or wished to be pregnant during the clinical trial period
  • Participants cannot use appropriate contraceptive method or do not want to use that from participation of study until one month after the end of administration of the investigational drug
  • Participants being considered as inappropriate for participation to the study for any medical or other reason as judged by the investigator

(New Participants):

  • Participants having serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychiatric conditions that, in the opinion of investigator, would compromise participation or be likely to lead to hospitalization during the course of the study
  • Participants having alanine aminotransferase or aspartate aminotransferase higher than 100 IU/L or total bilirubin higher than 1.6 mg/dL
  • Participants having serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or receiving renal dialysis
  • Participants having diagnosis seronegative spondyloarthropathy or rheumatoid arthritis
  • Participants having primary painful condition due to other than CLBP
  • Participants having a history of low back surgery
  • Participants having any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
  • Participants having major depressive disorder as determined using depression module of the Mini-International Neuropsychiatric Interview
  • Participants having uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension
  • Participants treating with a MAOI within 14 days or the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug
  • Participants answering "yes" to any of the questions about active suicidal ideation/intent/behaviors occurring within the past month (Columbia Suicide Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section)
  • Participants have known hypersensitivity to multiple medications
  • Participants are non-ambulatory or require the use of crutches or a walker
  • Participants having a history of substance abuse or dependence within the past year, excluding nicotine and caffeine
  • Participants having a positive urine drug screen for any substances of abuse
  • Participants have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
  • Participants have had previous exposure to duloxetine or completed / withdrawn from any study investigating duloxetine
  • Pregnant participants or participants who are breast-feeding, or wished to be pregnant during the clinical trial period
  • Participants cannot use appropriate contraceptive method or do not want to use that from participation of study until one month after the end of administration of the investigational drug
  • Participants being considered as inappropriate for participation to the study for any medical or other reason as judged by the investigator

Sites / Locations

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duloxetine

Arm Description

Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. Tapering week doses of 40 mg for first week and 20 mg for second week.

Outcomes

Primary Outcome Measures

Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's
A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.

Secondary Outcome Measures

Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50
A self-reported scale measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.
Patient Global Impression of Improvement (PGI-Improvement) to Week 50
PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).
Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50
CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50
RMDQ-24 is a participant completed questionnaire and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant was instructed to put a mark next to each appropriate statement. The number of statements marked was summed by the clinician for a total score. The total score ranged from 0 (no disability) to 24 (severe disability).
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50
SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.
Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm ranging from -0.111 to 1.0, with higher scores indicating better quality of life.
Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50
BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52
C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.
Number of Participants With Fall Events From Fall Questionnaire
Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) * 100.

Full Information

First Posted
July 31, 2013
Last Updated
December 18, 2015
Sponsor
Eli Lilly and Company
Collaborators
Shionogi
search

1. Study Identification

Unique Protocol Identification Number
NCT01914666
Brief Title
An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain
Official Title
Phase 3 Clinical Study of Duloxetine Hydrochloride in Patients With CLBP - Open Label Long Term Extension Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
Shionogi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to assess the long term safety of duloxetine in participants with Chronic Low Back Pain (CLBP).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain Lower Back Chronic
Keywords
Chronic Low Back Pain, CLBP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine
Arm Type
Experimental
Arm Description
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. Tapering week doses of 40 mg for first week and 20 mg for second week.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta, LY248686
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's
Description
A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Time Frame
Week 53
Secondary Outcome Measure Information:
Title
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50
Description
A self-reported scale measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.
Time Frame
Baseline, Week 50
Title
Patient Global Impression of Improvement (PGI-Improvement) to Week 50
Description
PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).
Time Frame
Week 50
Title
Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50
Description
CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Time Frame
Baseline, Week 50
Title
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50
Description
RMDQ-24 is a participant completed questionnaire and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant was instructed to put a mark next to each appropriate statement. The number of statements marked was summed by the clinician for a total score. The total score ranged from 0 (no disability) to 24 (severe disability).
Time Frame
Baseline, Week 50
Title
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50
Description
SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.
Time Frame
Baseline, Week 50
Title
Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50
Description
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm ranging from -0.111 to 1.0, with higher scores indicating better quality of life.
Time Frame
Baseline, Week 50
Title
Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50
Description
BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.
Time Frame
Baseline, Week 50
Title
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52
Description
C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.
Time Frame
Baseline, Week 53
Title
Number of Participants With Fall Events From Fall Questionnaire
Description
Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) * 100.
Time Frame
Week 53

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (Consecutive Participants): Participants who have completed the 15-week administration in the phase 3 clinical study of Duloxetine hydrochloride in participants with CLBP, study HMGY (NCT01855919) Female participants having child-bearing potential must test negative (-) on a pregnancy test (New Participants): Participants with CLBP present for the preceding 6 months or longer Participants used nonsteroidal anti-inflammatory drugs for CLBP for less than 14 days on average per month in the past 3 months and less than 14 days in one month prior to study Participants having a score of ≥4 on Brief Pain Inventory (BPI) average pain score at participation of study Female participants having child-bearing potential must test negative (-) on a pregnancy test Exclusion Criteria: (Consecutive Participants): Participants having serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychiatric conditions that, in the opinion of investigator, would compromise participation or be likely to lead to hospitalization during the course of the study Participants having alanine aminotransferase or aspartate aminotransferase higher than 100 International Units per Liter (IU/L) or total bilirubin higher than 1.6 milligram per deciliter (mg/dL) Participants having serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or receiving renal dialysis Participants having diagnosis seronegative spondyloarthropathy or rheumatoid arthritis Participants having primary painful condition due to other than CLBP Participants having uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension Participants treating with a monoamine oxidase inhibitor (MAOI) within 14 days or the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug Participants answering "yes" to any of the questions about active suicidal ideation/intent/behaviors occurring within the past month (Columbia Suicide Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section) Pregnant participants or participants who are breast-feeding, or wished to be pregnant during the clinical trial period Participants cannot use appropriate contraceptive method or do not want to use that from participation of study until one month after the end of administration of the investigational drug Participants being considered as inappropriate for participation to the study for any medical or other reason as judged by the investigator (New Participants): Participants having serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychiatric conditions that, in the opinion of investigator, would compromise participation or be likely to lead to hospitalization during the course of the study Participants having alanine aminotransferase or aspartate aminotransferase higher than 100 IU/L or total bilirubin higher than 1.6 mg/dL Participants having serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or receiving renal dialysis Participants having diagnosis seronegative spondyloarthropathy or rheumatoid arthritis Participants having primary painful condition due to other than CLBP Participants having a history of low back surgery Participants having any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder Participants having major depressive disorder as determined using depression module of the Mini-International Neuropsychiatric Interview Participants having uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension Participants treating with a MAOI within 14 days or the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug Participants answering "yes" to any of the questions about active suicidal ideation/intent/behaviors occurring within the past month (Columbia Suicide Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section) Participants have known hypersensitivity to multiple medications Participants are non-ambulatory or require the use of crutches or a walker Participants having a history of substance abuse or dependence within the past year, excluding nicotine and caffeine Participants having a positive urine drug screen for any substances of abuse Participants have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication Participants have had previous exposure to duloxetine or completed / withdrawn from any study investigating duloxetine Pregnant participants or participants who are breast-feeding, or wished to be pregnant during the clinical trial period Participants cannot use appropriate contraceptive method or do not want to use that from participation of study until one month after the end of administration of the investigational drug Participants being considered as inappropriate for participation to the study for any medical or other reason as judged by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559 ) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Saitama
ZIP/Postal Code
330-0063
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain

We'll reach out to this number within 24 hrs