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

Osteoarthritis Clinical Trial

Official title:

A Study to Comparing the Efficacy and Safety of the Ketoprofen and Diclofenac in Patients With Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04421911
• Other study ID #: KETO-2019
• Status: Completed
• Phase: Phase 3
• Start date: March 20, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: January 2021
• Source: Handok Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Ketoprofen topical
Ketoprofen topical for 21days
• Diclofenac Topical
Diclofenac topical for 21days

Locations

Country	Name	City	State
Russian Federation	Maksimum Zdorovya	Kemerovo
Russian Federation	City Clinical Hospital #1 n.a. Pirogova	Moscow
Russian Federation	Rostov State Medical University	Rostov-on-Don
Russian Federation	Ryazan State Medical University n.a. I.P.Pavlov	Ryazan
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	Ulyanovsk Regional Clinical Hospital	Ulyanovsk
Russian Federation	Regional Clinical Hospital	Vladimir
Russian Federation	Clinical Emergency Hospital n.a. N.V.Soloviev	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Handok Inc.

Country where clinical trial is conducted

Russian Federation, 

Outcome

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