CTRI/2015/02/005510
Completed
Phase 3
A prospective, randomized, double blind, two arm, parallel, placebo controlled, comparative, multicentre clinical study to evaluate the safety and efficacy of Dynapar QPS compared to placebo topical solution for treatment of osteoarthritis of knee
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Osteoarthritis of knee
- Sponsor
- Troikaa Pharmaceuticals Limited
- Enrollment
- 212
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients of either gender, 40\-65 years of age
- •2\.Patient fulfilling modified American College of Rheumatology (ACR) criteria for osteoarthritis of knee
- •3\.Patients on frequent oral analgesic treatment (at least 3 days per week during the previous 4 weeks) for at least past 4 weeks for the management of symptomatic unilateral or bilateral primary osteoarthritis of knee at the time of screening
- •4\.Patients with at least moderate intensity of pain (defined as score of greater than or equal to 4 on 10 point visual analogue scale) while performing a weight\-bearing activity e.g. walking, standing, climbing stairs during or at the end of washout period after screening
Exclusion Criteria
- •1\.History of major trauma or surgery in the study joint within previous 6 months at the time of screening
- •2\.History of acute inflammatory arthritis, pseudogout or crystal deposition disorder of the study knee joint
- •3\.Radiographic evidence suggestive of arthritis other than primary osteoarthritis
- •4\.Patients receiving prescription muscle relaxants, psychotropic agents (except tramadol) corticosteroids or any other drug affecting the evaluation of analgesic action; or taking supplements like glucosamine and chondroitin sulfate.
- •5\.Patients with alternative form of therapy i.e. physical manipulation, acupuncture etc.
- •6\.Intramuscular corticosteroids in past 4 weeks or; oral or topical corticosteroids in past 2 weeks at the time of screening
- •7\.Intra\-articular injection of any drug within past 4 weeks at the time of screening
- •8\.Patients with history of cardiovascular surgery i.e., coronary artery bypass graft or Percutaneous coronary intervention, within past 4 weeks at the time of screening
- •9\.Patients who require or scheduled for any surgery (including knee joint surgery) during study period
- •10\.Uncontrolled systemic disorders like diabetes mellitus, hypertension, or cardiac disorder requiring hospitalization
Outcomes
Primary Outcomes
Not specified
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