CTRI/2009/091/000300
Completed
Phase 3
COMPARATIVE ASSESSMENT OF THE EFFICACY, SAFETY AND TOLERABILITY OF DIACEREIN MR 100mg vs DIACEREIN 50mg IN ADULT PATIENTS WITH OSTEOARTHRITIS OF THE KNEE
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Glenmark Pharmaceuticals Ltd
- Enrollment
- 210
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and non\-pregnant females (with negative beta\-human chorionic gonadotropin test). Female patients on adequate contraceptive control.
- •Age: 30 to 70 years
- •Clinical and radiological diagnosis of osteoarthritis of the knee based on the American College of Rheumatology (ACR) Clinical Classification Criteria \[Appendix B].
- •Patients with a baseline Patient?s Assessment of Arthritis Pain\-VAS score of \> 40mm / 4cm, and both Patient?s and Physicians? Global Assessment of Arthritis of poor or very poor.
- •Patient willing to comply with study procedures and requirements.
Exclusion Criteria
- •Pregnant and nursing women.
- •Patients hypersensitive to any study medications and ingredients
- •Inflammatory arthritis, gout, pseudogout, Paget?s disease or any chronic pain syndrome that may interfere with assessment of the Index hip and/or knee.
- •Symptomatic bursitis or acute joint trauma of the Index hip and/or knee.
- •Conditions predisposing to gastrointestinal dysfunction (eg, history of peptic ulcer, upper gastrointestinal disease, ulcerative colitis; smoking; advancing age; concurrent corticosteroids; alcohol abuse; etc.).
- •History of bleeding tendencies, cirrhosis and esophageal varices.
- •History of hypersensitivity or allergy to NSAIDs, other COX\-2 inhibitors and/or sulphonamides.
- •Pre\-existing asthma.
- •Patients who would require concomitant therapy with drugs e.g. low dose aspirin, warfarin, anti\-epileptics, fluconazole (inhibitor of CYP 2C9/3A4\), ketoconazole (a known inhibitor of CYP 3A4\) etc.
- •Immunocompromised states and patients with systemic infections.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 3
EFFICACY, SAFETY AND TOLERABILITY OF SERTACONAZOLE 2% plus ZINC PYRITHIONE 1% SHAMPOO vs KETOCONAZOLE 2% SHAMPOO IN ADULT PATIENTS WITH DANDRUFFCTRI/2009/091/001079Glenmark Pharmaceuticals Ltd. Mumbai, India200
Completed
Phase 3
A clinical trial to study the effects of a fixed dose combination of two drugs Diacerein + Aceclofenac and aceclofenac on patients with osteoarthritisCTRI/2010/091/000081Glenmark Pharmaceuticals Ltd200
Completed
Phase 4
Comparison of effect,safety and cost of sertaconazole cream versus luliconazole cream in patients with dermatophytosesHealth Condition 1: null- DERMATOPHYTOSES PATIENTSHealth Condition 2: L088- Other specified local infections of the skin and subcutaneous tissueCTRI/2017/11/010418Government Medical College59
Completed
Phase 4
A clinical trial to compare the evaluation of efficacy, safety and tolerability of three expectorants in the treatment of productive cough associated with acute bronchitis, AECB, pneumonia and asthmatic bronchitis in Indian populatioCTRI/2009/091/000112Glenmark Pharmaceuticals LtdBD Sawant Marg, Chakala, Off. Western Express Highway, Andheri (E), Mumbai 400 099354
Completed
Phase 4
A COMPARATIVE STUDY TO EVALUATE EFFICACY AND SAFETY BETWEEN GABAPENTIN, PREGABALIN AND DULOXETINE IN PATIENTS WITH PAINFUL DIABETIC PERIPHERAL NEUROPATHYHealth Condition 1: null- Peripheral diabetic neuropathyCTRI/2009/091/001058Research society for the study of diabetes in India RSSDI152