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Efficacy and Safety of Dexketoprofen extended release tablet in the Treatment of Osteoarthritis

Phase 3
Completed
Registration Number
CTRI/2009/091/000932
Lead Sponsor
Emcure Pharmaceuticals Ltd, Pune
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
0
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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