A Study for Patient With Chronic Low Back Pain

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Drug: Duloxetine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 401
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sa Coma, Brazil, 04230000
    • 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.
  • São Paulo, Brazil, 04026-000
    • 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.
• Germany
  • Aalen, Germany, 73430
    • 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.
  • Alzenau, Germany, 63755
    • 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.
  • Berlin, Germany, 10629
    • 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.
  • Ellwangen, Germany, 73479
    • 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.
  • Hamburg, Germany, 20255
    • 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.
  • Wiesbaden, Germany, 65189
    • 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.
• Netherlands
  • Rotterdam, Netherlands, 3039 BD
    • 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.
• Poland
  • Krakow, Poland, 30-349
    • 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.
  • Lublin, Poland, 20-093
    • 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.
  • Poznan, Poland, 61-289
    • 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.
  • Szczecin, Poland, 70-376
    • 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.
• Russian Federation
  • Moscow, Russian Federation, 119992
    • 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.
• Spain
  • Barcelona, Spain, 08025
    • 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.
  • Bilboa, Spain, 48013
    • 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.
  • Getafe, Spain, 28905
    • 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.
  • La Coruña, Spain, 15006
    • 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.
  • Madrid, Spain, 28009
    • 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.
• United States
  • Arizona
    • Chandler, Arizona, United States, 85225
      • 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.
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • 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.
  • Florida
    • Deland, Florida, United States, 32720
      • 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.
    • Jacksonville, Florida, United States, 32216
      • 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.
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • 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.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • 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.
  • Oregon
    • Portland, Oregon, United States, 97210
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• 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 Dec;11(12):1282-90. doi: 10.1016/j.jpain.2010.03.002. Epub 2010 May 15.
• Williamson OD, Schroer M, Ruff DD, Ahl J, Margherita A, Sagman D, Wohlreich MM. Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clin Ther. 2014 Apr 1;36(4):544-51. doi: 10.1016/j.clinthera.2014.02.009. Epub 2014 Mar 17.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: October 3, 2008
• First Submitted That Met QC Criteria: October 6, 2008
• First Posted (Estimate): October 7, 2008

Study Record Updates

• Last Update Posted (Estimate): October 18, 2010
• Last Update Submitted That Met QC Criteria: September 30, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: 12360; F1J-MC-HMGC (Other Identifier: Eli Lilly and Company)