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

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Diclofenac Topical; Drug: Ketoprofen topical

• Registration Number: NCT04421911
• Lead Sponsor: Handok Inc.

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

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

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

Study Timeline

• Study Start: 2020-03-20
• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diclofenac	Diclofenac Topical	-
ketoprofen	Ketoprofen topical	-

Primary Outcome Measures

Name	Time	Method
Mean change in walking arthritis pain intensity score	3 weeks	Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Mean change in spontaneous arthritis pain intensity score	3 weeks	Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS)
Knee injury and Osteoarthritis Outcome Score (KOOS)	3 weeks	Mean change in individual parameters and the general normalized Knee injury and Osteoarthritis Outcome Score (KOOS) score (5-point scale)
Global Impression of Improvement (PGI-I)	3 weeks	Patient Global Impression of Improvement (PGI-I) assessment
Adverse events	3 weeks	frequency, severity, relationship with the study drug

Trial Locations

Locations (9)

City Clinical Hospital #1 n.a. Pirogova; 🇷🇺 Moscow, Russian Federation

Clinical Emergency Hospital n.a. N.V.Soloviev; 🇷🇺 Yaroslavl, Russian Federation

Maksimum Zdorovya; 🇷🇺 Kemerovo, Russian Federation

Ryazan State Medical University n.a. I.P.Pavlov; 🇷🇺 Ryazan, Russian Federation

Regional Clinical Hospital; 🇷🇺 Vladimir, Russian Federation

Saratov State Medical University n.a. V.I.Razumovsky; 🇷🇺 Saratov, Russian Federation

Private Healthcare Institution Smolensk Russian Railway Clinical Hospital; 🇷🇺 Smolensk, Russian Federation

Rostov State Medical University; 🇷🇺 Rostov-on-Don, Russian Federation

Ulyanovsk Regional Clinical Hospital; 🇷🇺 Ulyanovsk, Russian Federation