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

Handok

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis

Treatments

Drug: Diclofenac Topical

Drug: Ketoprofen topical

Study type

Interventional

Funder types

Industry

Identifiers

NCT04421911

KETO-2019

Details and patient eligibility

About

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

Full 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

Enrollment

236 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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