A Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain

NCT01855919 | Completed Phase 3 Results

• 2 other identifiers: 14376F1J-JE-HMGY
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the efficacy and 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)

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

  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.

  Baseline, Week 14

Secondary Outcomes (13)

• 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 BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores 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

• Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score at Week 14

  Baseline, Week 14

Study Arms (2)

Duloxetine

EXPERIMENTAL

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.

Drug: Duloxetine

Placebo

PLACEBO COMPARATOR

Placebo administered orally once every day for 15 weeks.

Drug: Placebo

Interventions

Duloxetine DRUG

Administered orally

Also known as: Cymbalta, LY248686

Duloxetine

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)
• Participants having a positive urine drug screen for any substances of abuse or excluded medication
• 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 uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension
• Participants have had previous exposure to duloxetine or completed / withdrawn from any study investigating duloxetine

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, Japan

Location

Related Publications (2)

• Enomoto H, Sasaki N, Fujikoshi S, Yoshikawa A, Tsuji T, Takeshita K. Relationship Between Pain Alleviation and Disease-specific Health-related Quality of Life Measures in Patients With Chronic Low Back Pain Receiving Duloxetine: Exploratory Post Hoc Analysis of a Japanese Phase 3 Randomized Study. J Am Acad Orthop Surg Glob Res Rev. 2019 Nov 27;3(11):e18.00086. doi: 10.5435/JAAOSGlobal-D-18-00086. eCollection 2019 Nov.

  PMID: 31875196 DERIVED

• Tsuji T, Itoh N, Ishida M, Ochiai T, Konno S. Response to duloxetine in chronic low back pain: exploratory post hoc analysis of a Japanese Phase III randomized study. J Pain Res. 2017 Sep 4;10:2157-2168. doi: 10.2147/JPR.S138172. eCollection 2017.

  PMID: 28919811 DERIVED

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

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

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 17, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 23, 2015
• Results First Posted: July 23, 2015

Record last verified: 2015-06

Locations

JP (1)