An Extension Study of Duloxetine in Osteoarthritis and Knee Pain (Extension of F1J-JE-HMGX, NCT02248480)

NCT02335346 | Completed Phase 3 Results

• 2 other identifiers: 15611F1J-JE-HMHD
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and efficacy of duloxetine in participants with osteoarthritis and knee pain. The study will last for 1 year.

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Drug Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)

  A summary of drug related (considered by the investigator) AEs and SAEs is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.

  Baseline through Week 53

Secondary Outcomes (8)

• Patient Global Impression-Improvement (PGI-I) at 50 Weeks

  Week 50

• Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Week 50

  Baseline, Week 50

• Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)

  Baseline, Week 50

• Change From Baseline to 50 Weeks on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score

  Baseline, Week 50

• Change From Baseline to 50 Weeks on the 36-Item Short-Form Health Survey (SF-36)

  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. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.

Drug: Duloxetine

Interventions

Duloxetine DRUG

Administered orally

Also known as: LY248686, Cymbalta

Duloxetine

Eligibility Criteria

• Age: 40 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 treatment in the preceding study HMGX.
• (New Participants)
• Participants with present osteoarthritis (OA) based on American College of Rheumatology (ACR) classification of idiopathic OA of the knee.
• Have pain for ≥14 days of each month for 3 months prior to study entry.
• Have a score of ≥4 on the BPI average pain score at the start of the study.
• (Consecutive and New Participants)
• Females of child-bearing potential must test negative (-) on a pregnancy test.

You may not qualify if:

• (New Participants)
• Participants who have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder.
• Participants who have major depressive disorder as determined using depression module of the Mini-International Neuropsychiatric Interview (M.I.N.I.).
• Participants who have received intrarticular hyaluronate or steroids, joint lavage, or other invasive therapies to the knee in the past 1 week.
• Participants who have had knee arthroscopy of the index knee within the past year or joint replacement of the index knee or osteotomy at any time.
• Participants have a prior synovial fluid analysis showing a white blood cell (WBC) ≥2000 cubic millimeters (mm3) that is indicative of a diagnosis other than OA.
• Participants who have a history of having more than one medical allergy.
• Are non-ambulatory or require the use of crutches or a walker.
• Have frequent falls that could result in hospitalization or could compromise response to treatment.
• Have a history of drug abuse or dependence within the past year, including alcohol and excluding nicotine and caffeine.
• Have a positive urine drug screen for any substances of abuse or excluded medication.
• Have received administration of another investigational drug within the 30 days prior to enrollment.
• Have had previous exposure to duloxetine or completed/withdrawn from any study investigating duloxetine.
• (Consecutive and New Participants)
• Participants who have serious cardiovascular, hepatic, renal, endocrine, respiratory, or hematologic illness, peripheral vascular disease, or other medical condition or neuropsychiatric conditions or clinically significant laboratory abnormalities or electrocardiographic abnormalities.

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.

Kobe, 650-0046, Japan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 9, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 18, 2019
• Results First Posted: November 7, 2017

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

JP (1)