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A Study of Duloxetine (LY248686) in Participants With Chronic Osteoarthritis and Knee Pain in Japan

CompletedPhase 3NCT02248480
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Effect of Duloxetine 60 mg Versus Placebo in Patients With Chronic Osteoarthritis and Knee Pain in Japan
Sponsor
Eli Lilly and Company
Collaborators
Shionogi
Start date
2014-10
Primary completion
2015-06
Sex
All
Age range
from 40 Years to 79 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Japan
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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. * Participants who have had knee arthroscopy of the index knee within the past year or joint replacement of the index knee or osteotomy at anytime. * Participants who have end-stage osteoarthritis or surgery planned during the trial for the index joint. * 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 taking any excluded medications that cannot be discontinued. * Participants anticipated by the investigator to require use of nonsteroidal anti-inflammatory drugs that include acetaminophe…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02248480