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Clinical Trials/NCT00767806
NCT00767806CompletedPhase 3

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

Eli Lilly and Company1 site in 1 country401 target enrollmentStarted: September 2008Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
401
Locations
1
Primary Endpoint
Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •Major depressive disorder.
  • •Daily use of narcotics.

Arms & Interventions

Duloxetine

Experimental

Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment

Intervention: Duloxetine (Drug)

Placebo

Placebo Comparator

Patients received placebo by mouth once daily for 12 weeks of double-blind treatment

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score

Time Frame: baseline, 12 weeks

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.

Secondary Outcomes

  • Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)(baseline, 12 weeks)
  • Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating(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(12 weeks)
  • Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint(12 weeks)
  • Number of Sustained Responders at 12 Week Endpoint(12 weeks)
  • Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution(12 weeks)
  • Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form(baseline, 12 weeks)
  • Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey(baseline, 12 weeks)
  • Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension(baseline, 12 weeks)
  • Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S)(baseline, 12 weeks)
  • Patient's Global Impression of Improvement (PGI-I) at 12 Weeks(12 weeks)
  • Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire(baseline, 12 weeks)
  • Participants Who Discontinued From Baseline to 12 Weeks(baseline, 12 weeks)
  • Change From Baseline to 12 Weeks in Uric Acid(baseline, 12 weeks)
  • Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)(baseline, 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Albumin(baseline, 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase(baseline, 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase(baseline, 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase(baseline, 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Creatinine(baseline, 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Total Protein(baseline, 12 weeks)
  • Change From Baseline to 12 Weeks in Blood Pressure(baseline, 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Weight(baseline, 12 weeks)
  • Change From Baseline to 12 Week Endpoint in Pulse Rate(baseline, 12 weeks)
  • Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale(baseline through 12 weeks)

Investigators

Sponsor Class
Industry

Study Sites (1)

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