Status:
COMPLETED
A Study to Assess Efficacy and Safety of the Ketoprofen vs Diclofenac
Lead Sponsor:
Handok Inc.
Conditions:
Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
Primary objective: • To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of primary endpoint : Mean change in walking arthritis pain intensity score Sec...
Detailed Description
This trial is designed as an open-label, multicenter, randomized, clinical study for assessment of efficacy and safety of Ketoprofen plaster and Diclofenac plaster in patients with osteoarthritis
Eligibility Criteria
Inclusion
- Patients aged 40-75 years
- Compliance to ACR diagnostic criteria of OA of the knee
- Patients with Kellgren-Lawrence grade 1-3
- Index knee pain should be ≥40 mm on VAS (100mm) scale
Exclusion
- Intolerance or allergic reactions to the study therapy
- Usage of NSAIDs within 3 days
- Open skin lesions or dermatological conditions at the site of plaster application
- Surgery or major trauma of the index knee within the previous 12 months
- Pregnant or breast-feeding women
- Alcohol addiction, drug addiction or drug abuse in the past
Key Trial Info
Start Date :
March 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT04421911
Start Date
March 20 2020
End Date
September 1 2020
Last Update
January 20 2021
Active Locations (9)
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1
Maksimum Zdorovya
Kemerovo, Russia
2
City Clinical Hospital #1 n.a. Pirogova
Moscow, Russia
3
Rostov State Medical University
Rostov-on-Don, Russia
4
Ryazan State Medical University n.a. I.P.Pavlov
Ryazan, Russia