Phase 3 Clinical Study of Duloxetine Hydrochloride in Patients With CLBP - Open Label Long Term Extension Study

Eli Lilly and Company1 site in 1 country151 target enrollmentSeptember 2013

ConditionsBack Pain Lower Back Chronic

InterventionsDuloxetine

DrugsDuloxetine

Overview

Phase: Phase 3
Intervention: Duloxetine
Conditions: Back Pain Lower Back Chronic
Sponsor: Eli Lilly and Company
Enrollment: 151
Locations: 1
Primary Endpoint: Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's
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 long term safety of duloxetine in participants with Chronic Low Back Pain (CLBP).

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

December 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•(Consecutive Participants):
•Participants who have completed the 15-week administration in the phase 3 clinical study of Duloxetine hydrochloride in participants with CLBP, study HMGY (NCT01855919)
•Female participants having child-bearing potential must test negative (-) on a pregnancy test
•(New Participants):
•Participants with CLBP present for the preceding 6 months or longer
•Participants used nonsteroidal anti-inflammatory drugs for CLBP for less than 14 days on average per month in the past 3 months and less than 14 days in one month prior to study
•Participants having a score of ≥4 on Brief Pain Inventory (BPI) average pain score at participation of study
•Female participants having child-bearing potential must test negative (-) on a pregnancy test

Exclusion Criteria

•(Consecutive Participants):
•Participants having serious or unstable cardiovascular, hepatic, renal, metabolic, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychiatric conditions that, in the opinion of investigator, would compromise participation or be likely to lead to hospitalization during the course of the study
•Participants having alanine aminotransferase or aspartate aminotransferase higher than 100 International Units per Liter (IU/L) or total bilirubin higher than 1.6 milligram per deciliter (mg/dL)
•Participants having serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or receiving renal dialysis
•Participants having diagnosis seronegative spondyloarthropathy or rheumatoid arthritis
•Participants having primary painful condition due to other than CLBP
•Participants having uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension
•Participants treating with a monoamine oxidase inhibitor (MAOI) within 14 days or the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug
•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)
•Pregnant participants or participants who are breast-feeding, or wished to be pregnant during the clinical trial period

Arms & Interventions

Duloxetine

Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. Tapering week doses of 40 mg for first week and 20 mg for second week.

Intervention: Duloxetine

Outcomes

Primary Outcomes

Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's

Time Frame: Week 53

A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.

Secondary Outcomes

Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50(Baseline, Week 50)
Patient Global Impression of Improvement (PGI-Improvement) to Week 50(Week 50)
Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50(Baseline, Week 50)
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50(Baseline, Week 50)
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50(Baseline, Week 50)
Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50(Baseline, Week 50)
Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50(Baseline, Week 50)
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52(Baseline, Week 53)
Number of Participants With Fall Events From Fall Questionnaire(Week 53)