CTRI/2009/091/000932
Completed
Phase 3
A Multicentric, Randomized, Comparative Clinical Trial to Evaluate the Efficacy and Safety of Dexketoprofen ER Tablet in the Treatment of Osteoarthritis
Emcure Pharmaceuticals Ltd, Pune0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Emcure Pharmaceuticals Ltd, Pune
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? Male or female patients between 40\-75 years of age.
- •? Willing to give written informed consent and willing to comply with trial protocol.
- •? Clinically and/or radiologically diagnosed to have OA or are known OA patients
- •? Patient and / or physician?s global assessment of arthritic condition as fair, poor or very poor.
- •? Patients with normal laboratory values.
- •? Patients not on any anti\-inflammatory or other therapy known to affect the study outcome.
Exclusion Criteria
- •? Patients with history of any drug allergy or intolerance to NSAIDs.
- •? Severe hypertension or uncontrolled hypertension
- •? Patients with H/O or evidence of renal, hepatic or neurologic diseases
- •? Uncontrolled diabetes
- •? Women who are pregnant, lactating, of child bearing potential who are not practicing effective methods of contraception.
- •? Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
Outcomes
Primary Outcomes
Not specified
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