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NCT Number: NCT04421911

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

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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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Maksimum Zdorovya, Kemerovo, Russia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketoprofen topical

Drug

Ketoprofen topical for 21days

Diclofenac Topical

Drug

Diclofenac topical for 21days

Primary outcomes

  1. Mean change in walking arthritis pain intensity score

    Time frame: 3 weeks

    Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS)

Secondary outcomes

  1. Mean change in spontaneous arthritis pain intensity score

    Time frame: 3 weeks

    Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS)

  2. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 3 weeks

    Mean change in individual parameters and the general normalized Knee injury and Osteoarthritis Outcome Score (KOOS) score (5-point scale)

  3. Global Impression of Improvement (PGI-I)

    Time frame: 3 weeks

    Patient Global Impression of Improvement (PGI-I) assessment

  4. Adverse events

    Time frame: 3 weeks

    frequency, severity, relationship with the study drug

Sponsors and collaborators

Lead sponsor

Handok Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 9, 2020
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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