Efficacy and Safety of S-Etodolac Fixed Dose Combination Gel Formulatio
- Registration Number
- CTRI/2010/091/000487
- Lead Sponsor
- Emcure Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
1. Male or female patients between 35 - 65 years of age.
2. Patients diagnosed to have knee osteoarthritis.
3. Patients not on any anti-inflammatory or other therapy known to affect the study outcome.
4. Willing to give written informed consent and willing to comply with the trial protocol.
1. Patients with known hypersensitivity to the study medications and/or history of any drug allergy or intolerance to NSAIDs.
2. Patients with the history of or evidence of any severe cardiac, renal, hepatic, neurologic or any other major medical or psychiatric illness.
3. Any contraindication to use of NSAID.
4. Women who are pregnant, lactating, of child bearing potential who are not practicing effective methods of contraception.
5. Drug addiction or alcoholism
6. 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
Name Time Method Responder rate (The patients with at least 20 % improvement in WOMAC total score).Timepoint: Baseline and after 14 days of therapy
- Secondary Outcome Measures
Name Time Method 1)Improvement in average VAS score. 2)Improvement in WOMAC scores for pain, stiffness and physical function.<br>Timepoint: Baseline and after 14 days of therapy