A Clinical Trial of YH23537 in Patients With Knee Osteoarthritis
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
1 other identifier
interventional
456
1 country
1
Brief Summary
The purpose of this study is to evaluate efficacy and safety of YH23537 versus celebrex in patients with knee osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 knee-osteoarthritis
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2016
CompletedStudy Start
First participant enrolled
May 2, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2017
CompletedJanuary 16, 2019
January 1, 2019
1.1 years
April 21, 2016
January 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in VAS score to assess pain at Week 12
baseline and week 12
Secondary Outcomes (6)
Change From Baseline in VAS score to assess pain at Week 4, 8
baseline, week 4 and week 8
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
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
Percentage From Baseline in WOMAC responder at Week 4, 8, 12
baseline, week 4, week 8 and week 12
Percentage of positive response(+1) in Patient Global Impression of Change (PGIC) at Week 12
week 12
- +1 more secondary outcomes
Other Outcomes (6)
Quality of life measured by SF-12 at Week 12
week 12
Percentage of patients who had taken rescue medication at week 12
week 12
Amount of rescue medication tablets taken following the investigational product
week 12
- +3 more other outcomes
Study Arms (3)
YH23537
EXPERIMENTALYH23537 750/1500/3000mg
Celebrex
ACTIVE COMPARATORCelecoxib 200mg
Placebo
PLACEBO COMPARATORYH23537 Placebo
Interventions
Drug: YH23537 750mg Drug: YH23537 1500mg Drug: YH23537 3000mg
Drug: YH23537 750mg placebo Drug: YH23537 1500mg placebo Drug: YH23537 3000mg placebo
Eligibility Criteria
You may qualify if:
- Signed Informed Consent
- Men and women ≥ 40 years of age
- Patients with knee osteoarthritis at one or both knee by ACR
You may not qualify if:
- Patients with known or suspected secondary knee osteoarthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KyungHee University Medical Center
Seoul, 02447, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yoon Je Cho, M.D, Ph.D
Kyunghee University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2016
First Posted
May 3, 2016
Study Start
May 2, 2016
Primary Completion
May 24, 2017
Study Completion
September 26, 2017
Last Updated
January 16, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share