None listed
Conditions
Interventions
Intervention1: Dexketoprofen Trometamol Gel for topical application: Local application
TID for 14 days
Control Intervention1: Diclofenac Gel for topical application.: Local application
TID For 14 days
Sponsors
Emcure Pharmaceuticals Limited, Pune.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Onkar C. Swami
Manager - Medical Services
Outcome results
None listed