Osteoarthritis | A Study of Duloxetine in Participants With Chronic Pain Due to Osteoarthritis in China
Osteoarthritis research study
What is the primary objective of this study?
The purpose of this study is to assess the efficacy and safety of duloxetine once daily compared with placebo on the reduction of pain due to osteoarthritis (OA) in knee or hip in participants in China.
Who is eligible to participate?
Inclusion Criteria: - Meet clinical and radiographic criteria for the diagnosis of OA of the knee or hip with pain for ≥14 days of each month for 3 months prior to study entry - Have a rating ≥4 on the Brief Pain Inventory (BPI) 24-hour average pain item (Question 3 of the BPI modified short form) at both Screening and Randomization Exclusion Criteria: - Have previously completed/withdrawn from this study or any other study investigating duloxetine (Note: Participants who have been previously screened for a duloxetine study other than this study and never received investigational product will be eligible for this study if they meet all current entry criteria) - Have had previous exposure to duloxetine - Have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder - Current (within 1 year of Screening) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Axis I diagnosis of major depressive disorder, anxiety disorders (excluding phobias), alcohol or eating disorders, as determined by the Mini-International Neuropsychiatric Interview or a previous diagnosis - Have a history of substance abuse or dependence within the past year, excluding nicotine and caffeine - Are taking any excluded medications that cannot be discontinued at Screening - Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or the potential need to use an MAOI during the study or within 5 days of discontinuation of investigational product - Have a positive urine drug screen for any substance of abuse or excluded medication - Have serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study - Have a history of recurrent seizures other than febrile seizures - Are judged clinically by the investigator to be at suicidal risk according to the Columbia - Suicide Severity Rating Scale (C-SSRS): a \"Yes\" answer to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the\"Suicidal Ideation\" portion of the C-SSRS or a \"Yes\" answer to any of the suicide related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the \"Suicidal Behavior\" portion of the C-SSRS, with the ideation/behavior having occurred within the previous month - Have uncontrolled narrow-angle glaucoma - Have acute liver injury (such as hepatitis) or severe cirrhosis - Have known hypersensitivity to duloxetine or any of the inactive ingredients or have frequent/severe allergic reactions to multiple medications - Have frequent falls that could result in hospitalization or could compromise response to treatment - Have a diagnosis of inflammatory arthritis [that is, rheumatoid arthritis (RA)] or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis) - Have received intra-articular hyaluronate/steroids, joint lavage, or other invasive therapies to the index joint in the previous 3 months - Have had arthroscopy of the index joint within the previous year or joint replacement of the index joint at any time - Have surgery of the index joint scheduled to occur during the trial or are anticipated by the investigator to require surgery for the treatment of the OA of the index hip or knee along the duration of the study - Have had a prior synovial fluid analysis showing a white blood cell (WBC) count ≥2000 cubic millimeter (mm3) that is indicative of a diagnosis other than OA - Are non-ambulatory or require the use of crutches or a walker - Have a body mass index >40 - Are anticipated by the investigator to require use of analgesic agents including, but not limited to, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, and opioids, or other excluded medication for the duration of the study
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
DuloxetineDouble Blind Treatment Phase: 60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks. Extension Treatment Phase: 60 mg duloxetine administered by mouth QD for 13 weeks. Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
PlaceboDouble Blind Treatment Phase: Placebo administered by mouth once a day (QD) for 13 weeks. Extension Treatment Phase: 60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD. Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
Start Date: September 2013
Completed Date: June 2015
Phase: Phase 3
Primary Outcome: Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score
Secondary Outcome: Patient Global Impressions of Improvement (PGI-I) Score
Study sponsors, principal investigator, and references
Principal Investigator: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM-5PM Eastern Time (UTC/GMT-5 hours, EST)
Lead Sponsor: Eli Lilly and Company