Expired Study
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Brighton, Massachusetts 02135


Purpose:

The purpose of this study is to determine if duloxetine reduces the severity of chronic low back pain.


Criteria:

Inclusion Criteria: - Male or female outpatients with chronic low back pain Exclusion Criteria: - Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study. - Acute liver injury (such as hepatitis) or severe cirrhosis. - Previous exposure to duloxetine. - Body Mass Index (BMI) over 40. - Major depressive disorder. - Daily use of narcotics.


Study is Available At:


Original ID:

12360


NCT ID:

NCT00767806


Secondary ID:

F1J-MC-HMGC


Study Acronym:


Brief Title:

A Study for Patient With Chronic Low Back Pain


Official Title:

Effect of Duloxetine 60 mg Once Daily Versus Placebo in Patients With Chronic Low Back Pain


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eli Lilly and Company


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

401


Enrollment Type:

Actual


Overall Contact Information

Official Name: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)
Study Director
Eli Lilly and Company

Study Dates

Start Date:September 2008
Completion Date:July 2009
Completion Type:Actual
Primary Completion Date:July 2009
Primary Completion Type:Actual
Verification Date:September 2010
Last Changed Date:September 30, 2010
First Received Date:October 3, 2008
First Results Date:June 24, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale
Time Frame:baseline through 12 weeks
Safety Issues:True
Description:The Columbia Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed t
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Week Endpoint in Pulse Rate
Time Frame:baseline, 12 weeks
Safety Issues:True
Description:Least Squares Mean values were controlled for investigator.
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Week Endpoint in Weight
Time Frame:baseline, 12 weeks
Safety Issues:True
Description:Least Squares Mean values were controlled for investigator.
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Weeks in Blood Pressure
Time Frame:baseline, 12 weeks
Safety Issues:True
Description:Least Squares Mean values were controlled for investigator.
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Week Endpoint in Total Protein
Time Frame:baseline, 12 weeks
Safety Issues:True
Description:Least Squares Mean values were controlled for investigator.
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Week Endpoint in Creatinine
Time Frame:baseline, 12 weeks
Safety Issues:True
Description:Least Squares Mean values were controlled for investigator.
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase
Time Frame:baseline, 12 weeks
Safety Issues:True
Description:Least Squares Mean values were controlled for investigator.
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase
Time Frame:baseline, 12 weeks
Safety Issues:True
Description:Least Squares Mean values were controlled for investigator.
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase
Time Frame:baseline, 12 weeks
Safety Issues:True
Description:Least Squares Mean values were controlled for investigator.
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Week Endpoint in Albumin
Time Frame:baseline, 12 weeks
Safety Issues:True
Description:Least Squares Mean values were controlled for investigator.
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Weeks in Uric Acid
Time Frame:baseline, 12 weeks
Safety Issues:True
Description:Least Squares Mean values were controlled for investigator.
Outcome Type:Secondary Outcome
Measure:Participants Who Discontinued From Baseline to 12 Weeks
Time Frame:baseline, 12 weeks
Safety Issues:True
Description:Reasons for discontinuation are listed in the participant flow.
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)
Time Frame:baseline, 12 weeks
Safety Issues:False
Description:WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension
Time Frame:baseline, 12 weeks
Safety Issues:False
Description:Generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generate
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
Time Frame:baseline, 12 weeks
Safety Issues:False
Description:The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summ
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
Time Frame:baseline, 12 weeks
Safety Issues:False
Description:The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety (Ten), depression-dejection (Dep), anxiety-hostility (Ang), fatigue (Fat), confusion (Con), and vigor (Vig). Item scores: 0 (not at all) to 4 (extremely). Each factor scores range
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire
Time Frame:baseline, 12 weeks
Safety Issues:False
Description:Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of
Outcome Type:Secondary Outcome
Measure:Patient's Global Impression of Improvement (PGI-I) at 12 Weeks
Time Frame:12 weeks
Safety Issues:False
Description:A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Least Squares Mean values were controlled for investigator and
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S)
Time Frame:baseline, 12 weeks
Safety Issues:False
Description:Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least Squares Mean values were controlled for investigator and baseline sev
Outcome Type:Secondary Outcome
Measure:Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution
Time Frame:12 weeks
Safety Issues:False
Description:The results presented are the cumulative number of participants reaching each threshold of BPI average pain reduction. The thresholds are given as percent reductions in BPI average pain score from the baseline score. BPI: a self-reported scale that measu
Outcome Type:Secondary Outcome
Measure:Number of Sustained Responders at 12 Week Endpoint
Time Frame:12 weeks
Safety Issues:False
Description:Sustained responders: participants with ≥30% reduction of BPI average pain rating from baseline to endpoint and baseline to earlier visit than last visit and who maintain a ≥20% reduction of BPI average pain rating from baseline at every visit between las
Outcome Type:Secondary Outcome
Measure:Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint
Time Frame:12 weeks
Safety Issues:False
Description:Response to treatment was defined as at least a 50% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain ex
Outcome Type:Secondary Outcome
Measure:Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint
Time Frame:12 weeks
Safety Issues:False
Description:Response to treatment was defined as at least a 30% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain ex
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating
Time Frame:baseline, 12 weeks
Safety Issues:False
Description:24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients completed the electronic diary at bedtime. The 11-point Likert scale was also used for as
Outcome Type:Secondary Outcome
Measure:Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
Time Frame:baseline, 12 weeks
Safety Issues:False
Description:BPI-S and BPI-I are self-reported scales 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 in past 24 hours, and pain right now. Interference scores:
Outcome Type:Primary Outcome
Measure:Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score
Time Frame:baseline, 12 weeks
Safety Issues:False
Description:A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least Squares Mean values were controlled for investigator and

Study Interventions

Intervention Type:Drug
Name:Duloxetine
Description:60 mg orally once daily for 12 weeks
Arm Name:Duloxetine
Other Name:Cymbalta
Intervention Type:Drug
Name:Placebo
Description:Placebo once daily orally for 12 weeks
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
Study Arm Type:Experimental
Arm Name:Duloxetine
Description:Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Eli Lilly and Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Skljarevski V, Zhang S, Desaiah D, Alaka KJ, Palacios S, Miazgowski T, Patrick K. Duloxetine Versus Placebo in Patients With Chronic Low Back Pain: A 12-Week, Fixed-Dose, Randomized, Double-Blind Trial. J Pain. 2010 May 14; [Epub ahead of print]
PMID:20472510

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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