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Completed

NCT Number: NCT02759198

A Clinical Trial of YH23537 in Patients With Knee Osteoarthritis

The purpose of this study is to evaluate efficacy and safety of YH23537 versus celebrex in patients with knee osteoarthritis.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

KyungHee University Medical Center

Seoul, 02447, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed Informed Consent
  • Men and women ≥ 40 years of age
  • Patients with knee osteoarthritis at one or both knee by ACR

Exclusion criteria

  • Patients with known or suspected secondary knee osteoarthritis
  • Other exclusions applied

Treatment and study plan

YH23537

Drug

Drug: YH23537 750mg Drug: YH23537 1500mg Drug: YH23537 3000mg

Other names: YH23537 750mg/1500mg/3000mg

Celecoxib

Drug

Drug: Celecoxib 200mg

Other names: Celecoxib 200mg

YH23537 placebo

Drug

Drug: YH23537 750mg placebo Drug: YH23537 1500mg placebo Drug: YH23537 3000mg placebo

Primary outcomes

  1. Change From Baseline in VAS score to assess pain at Week 12

    Time frame: baseline and week 12

Secondary outcomes

  1. Change From Baseline in VAS score to assess pain at Week 4, 8

    Time frame: baseline, week 4 and week 8

  2. Change From Baseline in Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) score at Week 4, 8, 12

    Time frame: baseline, week 4, week 8 and week 12

  3. Change From Baseline in WOMAC subgroup(pain, stiffness, difficulty performing daily activities) score at Week 4, 8, 12

    Time frame: baseline, week 4, week 8 and week 12

  4. Percentage From Baseline in WOMAC responder at Week 4, 8, 12

    Time frame: baseline, week 4, week 8 and week 12

  5. Percentage of positive response(+1) in Patient Global Impression of Change (PGIC) at Week 12

    Time frame: week 12

  6. Percentage of positive response(excellent, good and fair response) in Physician's Global Assessment of Response to Therapy (PGART) at Week 12

    Time frame: week 12

Other outcomes

  1. Quality of life measured by SF-12 at Week 12

    Time frame: week 12

  2. Percentage of patients who had taken rescue medication at week 12

    Time frame: week 12

  3. Amount of rescue medication tablets taken following the investigational product

    Time frame: week 12

  4. The number of days taken rescue medication following the investigational product

    Time frame: week 12

  5. Change From Baseline in Kellgren-Lawrence(KL) grading scale to assess the severity of knee osteoarthritis on a plain radiograph at Week 12

    Time frame: week 12

  6. Change From Baseline in International knee documentation committee(IKDC) score at Week 4, 8, 12

    Time frame: week 4, 8, 12

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo- and Active-Controlled, Multicenter, Phase 2 Trial to Evaluate the Efficacy and Safety of YH23537 in Patients With Osteoarthritis of the Knee

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 3, 2016
Registry last updated
Jan 16, 2019

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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