A clinical trial to assess the efficacy and safety of topical Dexketoprofen Trometamol Gel in the treatment of knee osteoarthritis
- Registration Number
- CTRI/2009/091/000274
- Lead Sponsor
- Emcure Pharmaceuticals Limited, Pune.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1) Male or female patients between 40- 65 years of age.
2) Patients diagnosed to have knee osteoarthritis.
3) Willing to give written informed consent and willing to comply with the trial protocol.
4) Patients not on any anti-inflammatory or other therapy known to affect the study outcome.
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 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) Any condition that, in the opinion of the investigator, does not justify the patients's inclusion in the study.
6) Drug addiction or alcoholism
7) Current participation or participation within the previous three months in other clinical trials.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary efficacy variable is responder rate. The patients with at least 20 % improvement in pain intensity difference (PID) or WOMAC total score (0-4 Likert scale) will be termed as responders.Timepoint: 0, 14 days
- Secondary Outcome Measures
Name Time Method Improvement in average VAS score. Improvement in WOMAC scores for pain, stiffness and physical function. Improvement in patient's and physician's global assessment of arthritis.Timepoint: 0, 14 days