ClinicalTrials.Veeva

Menu

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

H

Handok

Status and phase

Completed
Phase 3

Conditions

Osteoarthritis

Treatments

Drug: Diclofenac Topical
Drug: Ketoprofen topical

Study type

Interventional

Funder types

Industry

Identifiers

NCT04421911
KETO-2019

Details and patient eligibility

About

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

Full 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

Enrollment

236 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

236 participants in 2 patient groups

ketoprofen
Experimental group
Treatment:
Drug: Ketoprofen topical
Diclofenac
Active Comparator group
Treatment:
Drug: Diclofenac Topical

Trial contacts and locations

9

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems