None listed
Conditions
Interventions
Intervention1: Fixed Dose Combination (FDC) of S(+) Etodolac 5% Gel Formulation: 2 gram (gm) three times in a day, locally
Intervention2: Fixed Dose Combination (FDC) of S(+) Etodolac 10% Gel Formulat
Sponsors
Emcure Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder rate (The patients with at least 20 % improvement in WOMAC total score).Timepoint: Baseline and after 14 days of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Improvement in average VAS score. 2)Improvement in WOMAC scores for pain, stiffness and physical function. Timepoint: Baseline and after 14 days of therapy | — |
Countries
India
Contacts
Public ContactDr. Onkar Swami, MD
Outcome results
None listed