A Clinical Trial of YH23537 in Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02759198
• Other study ID #: YH23537-202
• Status: Completed
• Phase: Phase 2
• Start date: May 2, 2016
• Est. completion date: September 26, 2017

Study information

• Verified date: January 2019
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: September 26, 2017
• Est. primary completion date: May 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• YH23537
Drug: YH23537 750mg Drug: YH23537 1500mg Drug: YH23537 3000mg
• Celecoxib
Drug: Celecoxib 200mg
• YH23537 placebo
Drug: YH23537 750mg placebo Drug: YH23537 1500mg placebo Drug: YH23537 3000mg placebo

Locations

Country	Name	City	State
Korea, Republic of	KyungHee University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life measured by SF-12 at Week 12		week 12
Other	Percentage of patients who had taken rescue medication at week 12		week 12
Other	Amount of rescue medication tablets taken following the investigational product		week 12
Other	The number of days taken rescue medication following the investigational product		week 12
Other	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
Other	Change From Baseline in International knee documentation committee(IKDC) score at Week 4, 8, 12		week 4, 8, 12
Primary	Change From Baseline in VAS score to assess pain at Week 12		baseline and week 12
Secondary	Change From Baseline in VAS score to assess pain at Week 4, 8		baseline, week 4 and week 8
Secondary	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
Secondary	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
Secondary	Percentage From Baseline in WOMAC responder at Week 4, 8, 12		baseline, week 4, week 8 and week 12
Secondary	Percentage of positive response(+1) in Patient Global Impression of Change (PGIC) at Week 12		week 12
Secondary	Percentage of positive response(excellent, good and fair response) in Physician's Global Assessment of Response to Therapy (PGART) at Week 12		week 12