An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain

NCT01914666 | Completed Phase 3 Results

• 2 other identifiers: 14949F1J-JE-HMHC
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Back Pain Lower Back Chronic

Keywords

Chronic Low Back Pain; CLBP

Outcome Measures

Primary Outcomes (1)

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

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

  Week 53

Secondary Outcomes (9)

• 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

Study Arms (1)

Duloxetine

EXPERIMENTAL

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.

Drug: Duloxetine

Interventions

Duloxetine DRUG

Administered orally

Also known as: Cymbalta, LY248686

Duloxetine

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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
• Participants cannot use appropriate contraceptive method or do not want to use that from participation of study until one month after the end of administration of the investigational drug
• Participants being considered as inappropriate for participation to the study for any medical or other reason as judged by the investigator
• (New 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 IU/L or total bilirubin higher than 1.6 mg/dL

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Shionogi: collaborator

Study Sites (1)

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.

Saitama, 330-0063, Japan

Location

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

FAS:all randomized pts who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) score. 1 Naïve group pt received at least 1 dose of study drug but had no post-dose data and not included in FAS.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559 ) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 2, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 27, 2016
• Results First Posted: January 27, 2016

Record last verified: 2015-12

Locations

JP (1)