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

Eli Lilly and Company1 site in 1 country458 target enrollmentMay 2013

ConditionsBack Pain Lower Back Chronic

InterventionsDuloxetine Placebo

DrugsDuloxetine Placebo

Overview

Phase: Phase 3
Intervention: Duloxetine
Conditions: Back Pain Lower Back Chronic
Sponsor: Eli Lilly and Company
Enrollment: 458
Locations: 1
Primary Endpoint: Change From Baseline to Week 14 in Brief Pain Inventory (BPI) 24-Hour Average Pain Severity Item
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to assess the efficacy and safety of duloxetine in participants with Chronic Low Back Pain (CLBP).

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

July 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Participants have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
•Participants having a history of low back surgery
•Participants having received epidural steroids, facet block, nerve block or other invasive procedures aimed to reduce low back pain within one month prior to screening
•Participants who have any difficulties to fulfill diary appropriately
•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 primary painful condition due to other than CLBP
•Participants being anticipated by the investigator to require use of nonsteroidal anti-inflammatory drugs and includes acetaminophen, opioid analgesics, or other excluded medication for the duration of the study
•Participants being considered as inappropriate for participation to the study for any medical or other reason as judged by the investigator
•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)

Arms & Interventions

Duloxetine

Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for first 3 days and 20 mg for last 4 days of week.

Intervention: Duloxetine

Placebo

Placebo administered orally once every day for 15 weeks.

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline to Week 14 in Brief Pain Inventory (BPI) 24-Hour Average Pain Severity Item

Time Frame: Baseline, Week 14

BPI is a self-reported scale that measures the severity of pain based on the average pain during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Higher scores indicated worsening of pain. Least squares (LS) means calculated using mixed model repeating measure (MMRM) adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.

Secondary Outcomes

Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score at Week 14(Baseline, Week 14)
Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14(Baseline, Week 14)
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Instrument to Week 14(Baseline, Week 14)
Percentage of Participants With Fall Events in Fall Questionnaire(Baseline through Week 14)
Patient Global Impression of Improvement (PGI-I) at Week 14(Week 14)
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 14(Baseline, Week 14)
Change From Baseline in Weekly Mean of 24 Hour Average Pain and Worst Daily Pain Severity Scores to Week 14(Baseline, Week 14)
Number of Participants With Suicidal Thoughts And Behaviors During Study [Columbia Suicide Severity Rating Scale (C-SSRS)](Baseline through Week 14)
Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 14(Baseline, Week 14)
Percentage of Participants With Sustained Pain Reduction in BPI Average Pain Score(Baseline through Week 14)
Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 14(Baseline, Week 14)
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 14(Baseline, Week 14)
Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 14(Baseline, Week 14)