Health Condition 1: M171- Unilateral primary osteoarthritisof knee
Conditions
Interventions
Intervention1: GRC 27864: 10 mg QD orally for 12 weeks
Intervention2: GRC 27864: 25 mg QD orally for 12 weeks
Intervention3: GRC 27864: 75 mg QD orally for 12 weeks
Control Intervention1: Placebo: QD
Sponsors
Glenmark Pharmaceuticals SA
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactAmol Pendse
Glenmark Pharmaceutical Ltd.
Outcome results
None listed