None listed
Conditions
Interventions
Intervention1: Dexketoprofen Extended Release Tablets: 75 mg OD
Control Intervention1: Dexketoprofen Immediate Release tablets: 25 mg TID
Sponsors
Emcure Pharmaceuticals Ltd, Pune
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder rate (patients with at least 20% improvement in WOMAC total Score)Timepoint: Baseline, after 14 and 28 days of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Improvement in average VAS score 2)Improvement in average WOMAC scores for pain, stiffness and physical function 3)Improvement in patient?s and physician?s global assessment of arthritis.Timepoint: Baseline, after 14 and 28 days of therapy. | — |
Countries
India
Contacts
Public ContactDr. Onkar Swami, MBBS; MD.
Manager - Medical Services
Outcome results
None listed