A Study for Patient With Chronic Low Back Pain

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

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

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Drug: Duloxetine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duloxetine<br>Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment | Drug: Duloxetine<br>* 60 mg orally once daily for 12 weeks<br>* Other names: LY248686;|
| Placebo Comparator: Placebo<br>Patients received placebo by mouth once daily for 12 weeks of double-blind treatment | Drug: Placebo<br>* Placebo once daily orally for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score | 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 baseline severity. | baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) | 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: 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. | baseline, 12 weeks | 
| Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating | 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 assessment of night pain and worst pain each day, and evaluated as weekly means. Least Squares Mean values were controlled for investigator and baseline severity. | baseline, 12 weeks | 
| Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint | 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 experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint. | 12 weeks | 
| Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint | 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 experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint. | 12 weeks | 
| Number of Sustained Responders at 12 Week Endpoint | 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 last visit and earlier visit. BPI: a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of sustained responders was assessed at endpoint. | 12 weeks | 
| Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution | 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 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). Number of participants under each threshold was assessed at endpoint. | 12 weeks | 
| Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S) | 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 severity. | baseline, 12 weeks | 
| Patient's Global Impression of Improvement (PGI-I) at 12 Weeks | 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 baseline severity. | 12 weeks | 
| Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire | 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 statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Least Squares Mean values were controlled for investigator and baseline severity. | baseline, 12 weeks | 
| Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form | 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 from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig) and ranges from 0 (least disturbed) to 80 (most disturbed). | baseline, 12 weeks | 
| Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey | 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 summary scores (mental component summary [MCS] and physical component summary [PCS]). The score for each of the domain and component summary=0-100 (higher scores indicate better health status or functioning). | baseline, 12 weeks | 
| Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension | 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 generated for each domain. For each patient, the outcome rating on 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1; higher scores indicate a better health state perceived by the patient. Participants were evaluated with the United Kingdom (UK) and the United States (US) population based index score. | baseline, 12 weeks | 
| Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) | 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 effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Absenteeism Presenteeism Work productivity loss Activity Impairment Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment. | baseline, 12 weeks | 
| Participants Who Discontinued From Baseline to 12 Weeks | Reasons for discontinuation are listed in the participant flow. | baseline, 12 weeks | 
| Change From Baseline to 12 Weeks in Uric Acid | Least Squares Mean values were controlled for investigator. | baseline, 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Albumin | Least Squares Mean values were controlled for investigator. | baseline, 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase | Least Squares Mean values were controlled for investigator. | baseline, 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase | Least Squares Mean values were controlled for investigator. | baseline, 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase | Least Squares Mean values were controlled for investigator. | baseline, 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Creatinine | Least Squares Mean values were controlled for investigator. | baseline, 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Total Protein | Least Squares Mean values were controlled for investigator. | baseline, 12 weeks | 
| Change From Baseline to 12 Weeks in Blood Pressure | Least Squares Mean values were controlled for investigator. | baseline, 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Weight | Least Squares Mean values were controlled for investigator. | baseline, 12 weeks | 
| Change From Baseline to 12 Week Endpoint in Pulse Rate | Least Squares Mean values were controlled for investigator. | baseline, 12 weeks | 
| Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale | 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 to determine if a suicide-related thought or behavior occurred. | baseline through 12 weeks |