A study to evaluate safety and efficacy of GRC 27864 in patients with hip / knee osteoarthritis pai
- Conditions
- Health Condition 1: M171- Unilateral primary osteoarthritisof knee
- Registration Number
- CTRI/2018/01/011109
- Lead Sponsor
- Glenmark Pharmaceuticals SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 624
1. Male and female subjects aged 40 years to 70 years (both inclusive) at the time of signing the ICF
2. Subjects diagnosed with primary osteoarthritis of the hip or knee for at least 3 months in accordance with American College of Rheumatology (ACR) clinical and radiological criteria
3. Subjects who may or may not have received an NSAID or other oral analgesic therapy and report moderate pain intensity on 0-100 Visual Analogue Scale
1. Subjects experiencing severe pain, on 0-100 Visual Analogue Scale in most severely affected joint
2. Subjects who have history or presence of signs/symptoms suggestive active peptic ulcer disease and gastrointestinal (GI) bleeding
3. Subjects with known aspirin allergy, allergic reaction to non-steroidal anti-inflammatory drugs (NSAIDs) including asthma and urticaria
4. Use of NSAIDs, COX-2 inhibitors or aspirin (except aspirin up to 100 mg daily for cardio-protection) within previous 7 days of randomization
5. Use of oral, intra-articular or intramuscular corticosteroid or intra-articular hyaluronic acid within 12 weeks before randomization
6. Subjects with a history of myocardial infarction, coronary artery bypass grafting/ percutaneous coronary intervention, unstable angina, stroke or transient ischemic attack, congestive heart failure (CHF) with symptoms at rest or with minimal activity
7. Subjects with inherited or acquired disorders in platelet function, bleeding or coagulation or requiring anti-coagulation (except low dose aspirin for cardioprotection)
8. Presence of any clinically significant illness or disease; any condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results
9. Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV) and Hepatitis C virus (HCV) at screening
10. Females who are pregnant or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change from baseline in the Western Ontario and McMasterâ??s University Osteoarthritis Index 3.1 pain subscale (WOMAC-PS) at the end of treatmentTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Biomarker assessmentTimepoint: Day 85;Incidence of TEAEs and SAEsTimepoint: Throughout study duration;Mean change from baseline in the Investigator Global Assessment of Response to Therapy (IGART) using 0-4 point Likert scaleTimepoint: 2, 4, 8 and 12 weeks of treatment and at follow up (14 weeks);Mean change from baseline in the Patient Global Assessment of Response to Therapy (PGART) using 0-4 point Likert scaleTimepoint: 2, 4, 8 and 12 weeks of treatment and at follow up (14 weeks);PK and PD assessmentTimepoint: Day 1 and Day 85;Proportion of subjects meeting OMERACT-OARSI responder criteriaTimepoint: 4 and 12 weeks