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A Clinical Trial of YH23537 in Patients With Knee Osteoarthritis

Sponsor
Yuhan Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02759198
Collaborator
(none)
456
Enrollment
1
Location
3
Arms
16.8
Actual Duration (Months)
27.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
456 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
May 2, 2016
Actual Primary Completion Date :
May 24, 2017
Actual Study Completion Date :
Sep 26, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: YH23537

YH23537 750/1500/3000mg

Drug: YH23537
Drug: YH23537 750mg Drug: YH23537 1500mg Drug: YH23537 3000mg
Other Names:
  • YH23537 750mg/1500mg/3000mg

    		•
    Active Comparator: Celebrex

    Celecoxib 200mg

    Drug: Celecoxib
    Drug: Celecoxib 200mg
    Other Names:
  • Celecoxib 200mg

    		•
    Placebo Comparator: Placebo

    YH23537 Placebo

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

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in VAS score to assess pain at Week 12 [baseline and week 12]

    Secondary Outcome Measures

    1. Change From Baseline in VAS score to assess pain at Week 4, 8 [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 [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 [baseline, week 4, week 8 and week 12]

    4. Percentage From Baseline in WOMAC responder at Week 4, 8, 12 [baseline, week 4, week 8 and week 12]

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

    Other Outcome Measures

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

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

    3. Amount of rescue medication tablets taken following the investigational product [week 12]

    4. The number of days taken rescue medication following the investigational product [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 [week 12]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 KyungHee University Medical Center Seoul Korea, Republic of 02447

    Sponsors and Collaborators

    • Yuhan Corporation

    Investigators

    • Study Chair: Yoon Je Cho, M.D, Ph.D, Kyunghee University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuhan Corporation
    ClinicalTrials.gov Identifier:
    NCT02759198
    Other Study ID Numbers:
    • YH23537-202
    First Posted:
    May 3, 2016
    Last Update Posted:
    Jan 16, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Celecoxib

    Study Results

    No Results Posted as of Jan 16, 2019