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

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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Ketoprofen topical; Drug: Diclofenac Topical

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 Type: Interventional
• Enrollment (Actual): 236
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Kemerovo, Russian Federation
    • Maksimum Zdorovya
  • Moscow, Russian Federation
    • City Clinical Hospital #1 n.a. Pirogova
  • Rostov-on-Don, Russian Federation
    • Rostov State Medical University
  • Ryazan, Russian Federation
    • Ryazan State Medical University n.a. I.P.Pavlov
  • Saratov, Russian Federation
    • Saratov State Medical University n.a. V.I.Razumovsky
  • Smolensk, Russian Federation
    • Private Healthcare Institution Smolensk Russian Railway Clinical Hospital
  • Ulyanovsk, Russian Federation
    • Ulyanovsk Regional Clinical Hospital
  • Vladimir, Russian Federation
    • Regional Clinical Hospital
  • Yaroslavl, Russian Federation
    • Clinical Emergency Hospital n.a. N.V.Soloviev

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Diclofenac	Drug: Diclofenac Topical; Diclofenac topical for 21days
EXPERIMENTAL: ketoprofen	Drug: Ketoprofen topical; Ketoprofen topical for 21days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in spontaneous arthritis pain intensity score	Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS)	3 weeks
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
Global Impression of Improvement (PGI-I)	Patient Global Impression of Improvement (PGI-I) assessment	3 weeks
Adverse events	frequency, severity, relationship with the study drug	3 weeks

Collaborators and Investigators

• Sponsor: Handok Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2020
• Primary Completion (ACTUAL): September 1, 2020
• Study Completion (ACTUAL): September 1, 2020

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (ACTUAL): June 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: osteoarthritis; ketoprofen; diclofenac
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac; Ketoprofen
• Other Study ID Numbers: KETO-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No