A Study to Assess Efficacy and Safety of the Ketoprofen vs Diclofenac

• Status: Completed
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

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

Secondary objectives:

• To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of secondary endpoints.

• To assess safety and tolerability of the Ketoprofen compared with Diclofenac based on the nature and frequency of adverse events in treatment groups

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Handok Inc.
• Treatments: Diclofenac; Ketoprofen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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