A Clinical Trial of YH23537 in Patients With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YH23537
Celecoxib
YH23537 placebo
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
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
Sites / Locations
- KyungHee University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
YH23537
Celebrex
Placebo
Arm Description
YH23537 750/1500/3000mg
Celecoxib 200mg
YH23537 Placebo
Outcomes
Primary Outcome Measures
Change From Baseline in VAS score to assess pain at Week 12
Secondary Outcome Measures
Change From Baseline in VAS score to assess pain at Week 4, 8
Change From Baseline in Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) score at Week 4, 8, 12
Change From Baseline in WOMAC subgroup(pain, stiffness, difficulty performing daily activities) score at Week 4, 8, 12
Percentage From Baseline in WOMAC responder at Week 4, 8, 12
Percentage of positive response(+1) in Patient Global Impression of Change (PGIC) at Week 12
Percentage of positive response(excellent, good and fair response) in Physician's Global Assessment of Response to Therapy (PGART) at Week 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02759198
Brief Title
A Clinical Trial of YH23537 in Patients With Knee Osteoarthritis
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2016 (Actual)
Primary Completion Date
May 24, 2017 (Actual)
Study Completion Date
September 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate efficacy and safety of YH23537 versus celebrex in patients with knee osteoarthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
456 (Actual)
8. Arms, Groups, and Interventions
Arm Title
YH23537
Arm Type
Experimental
Arm Description
YH23537 750/1500/3000mg
Arm Title
Celebrex
Arm Type
Active Comparator
Arm Description
Celecoxib 200mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
YH23537 Placebo
Intervention Type
Drug
Intervention Name(s)
YH23537
Other Intervention Name(s)
YH23537 750mg/1500mg/3000mg
Intervention Description
Drug: YH23537 750mg Drug: YH23537 1500mg Drug: YH23537 3000mg
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Celecoxib 200mg
Intervention Description
Drug: Celecoxib 200mg
Intervention Type
Drug
Intervention Name(s)
YH23537 placebo
Intervention Description
Drug: YH23537 750mg placebo Drug: YH23537 1500mg placebo Drug: YH23537 3000mg placebo
Primary Outcome Measure Information:
Title
Change From Baseline in VAS score to assess pain at Week 12
Time Frame
baseline and week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in VAS score to assess pain at Week 4, 8
Time Frame
baseline, week 4 and week 8
Title
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
Title
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
Title
Percentage From Baseline in WOMAC responder at Week 4, 8, 12
Time Frame
baseline, week 4, week 8 and week 12
Title
Percentage of positive response(+1) in Patient Global Impression of Change (PGIC) at Week 12
Time Frame
week 12
Title
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 Pre-specified Outcome Measures:
Title
Quality of life measured by SF-12 at Week 12
Time Frame
week 12
Title
Percentage of patients who had taken rescue medication at week 12
Time Frame
week 12
Title
Amount of rescue medication tablets taken following the investigational product
Time Frame
week 12
Title
The number of days taken rescue medication following the investigational product
Time Frame
week 12
Title
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
Title
Change From Baseline in International knee documentation committee(IKDC) score at Week 4, 8, 12
Time Frame
week 4, 8, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon Je Cho, M.D, Ph.D
Organizational Affiliation
Kyunghee University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
KyungHee University Medical Center
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Trial of YH23537 in Patients With Knee Osteoarthritis
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