Effect of Duloxetine 60 mg Versus Placebo in Patients With Chronic Osteoarthritis and Knee Pain in Japan

Eli Lilly and Company1 site in 1 country354 target enrollmentOctober 2014

ConditionsOsteoarthritis of the Knee

InterventionsDuloxetine Placebo

DrugsDuloxetine Placebo

Overview

Phase: Phase 3
Intervention: Duloxetine
Conditions: Osteoarthritis of the Knee
Sponsor: Eli Lilly and Company
Enrollment: 354
Locations: 1
Primary Endpoint: Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main purpose of this study is to evaluate the efficacy of the study drug known as duloxetine in participants with chronic osteoarthritis (OA) and knee pain in Japan.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

June 2015

Last Updated

6 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 present OA.
•Have pain for ≥ 14 days of each month for 3 months prior to study entry.
•Participants must have a score of ≥4 on the BPI average pain score before randomization.
•Females of child-bearing potential must test negative (-) on a pregnancy test.

Exclusion Criteria

•Participants who cannot appropriately complete the daily diaries.
•Have a score change of ≧3 on BPI 24-hour average pain score between screening and baseline.
•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.
•Participants who have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) higher than 100 international units per liter (IU/L) or total bilirubin higher than 1.6 milligrams/deciliter (mg/dL).
•Participants who have serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or are receiving renal dialysis.
•Participants who have a diagnosis of inflammatory arthritis (that is, rheumatoid arthritis) or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis and Type 1 diabetes).
•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 uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension.
•Participants who have received intrarticular hyaluronate or steroids, joint lavage, or other invasive therapies to the knee in the past 1 month.

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 three days and 20 mg for four days.

Intervention: Duloxetine

Placebo

Placebo administered orally once a day for 15 weeks.

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score

Time Frame: Baseline, Week 14

Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and BPI average pain severity at baseline as covariates.

Secondary Outcomes

Change From Baseline in Patient Global Impression of Improvement (PGI-Improvement)(Baseline, 14 Weeks)
Change From Baseline on the Patient Global Assessment Illness (PGAI) Score(Baseline, Week 14)
Change From Baseline on Weekly Mean of the 24-Hour Average Pain and Worst Pain Score(Baseline, Week 14)
Change From Baseline on the Clinical Global Impression of Severity (CGI-S)(Baseline, Week 14)
Change in Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S, BPI-I) Change From Baseline in BPI Pain Severity Items and Interference Items Score(Baseline, Week 14)
Change From Baseline on the WOMAC Questionnaire Stiffness Subscale(Baseline, 14 Weeks)
Change From Baseline on the 36-Item Short-Form Health Survey (SF-36)(Baseline, Week 14)
Percentage of Participants With a 30% and 50% Reduction in Average Pain Score on Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale(Baseline,Week 14)
Change From Baseline on the WOMAC Questionnaire Pain Subscale(Baseline, 14 Weeks)
Change From Baseline on the WOMAC Questionnaire Physical Function Subscale(Baseline, 14 Weeks)
Change From Baseline on the Beck Depression Inventory (BDI-II) Total Score(Baseline, Week 14)
Change From Baseline on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument(Baseline, Week 14)
Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score(Baseline, Week 14)
Percentage of Participants With Fall Events From Fall Questionnaire(Baseline through Week 14)
Change From Baseline on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score(Baseline, Week 14)
Percentage of Participants With a Responder Rate Based on OMERACT-OARSI Criteria(Baseline, Week 14)