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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02759198

Enrollment

456

Registered

2016-05-03

Start date

2016-05-02

Completion date

2017-09-26

Last updated

2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief summary

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

Interventions

DRUGYH23537

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

DRUGCelecoxib

Drug: Celecoxib 200mg

DRUGYH23537 placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change From Baseline in VAS score to assess pain at Week 12	baseline and week 12

Secondary

Measure	Time frame
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
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

Measure	Time frame
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
The number of days taken rescue medication following the investigational product	week 12
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
Change From Baseline in International knee documentation committee(IKDC) score at Week 4, 8, 12	week 4, 8, 12
Quality of life measured by SF-12 at Week 12	week 12

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026