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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04421911

Enrollment

236

Registered

2020-06-09

Start date

2020-03-20

Completion date

2020-09-01

Last updated

2021-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

ketoprofen, diclofenac, osteoarthritis

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

Interventions

DRUGKetoprofen topical

Ketoprofen topical for 21days

DRUGDiclofenac Topical

Diclofenac topical for 21days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026