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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-20

Study Completion Date

2020-09-01

Brief Summary

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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

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Detailed Description

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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

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ketoprofen

Group Type EXPERIMENTAL

Ketoprofen topical

Intervention Type DRUG

Ketoprofen topical for 21days

Diclofenac

Group Type ACTIVE_COMPARATOR

Diclofenac Topical

Intervention Type DRUG

Diclofenac topical for 21days

Interventions

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Ketoprofen topical

Ketoprofen topical for 21days

Intervention Type DRUG

Diclofenac Topical

Diclofenac topical for 21days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No