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

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: YH23537; Drug: Celecoxib; Drug: YH23537 placebo

• Study Type: Interventional
• Enrollment (Actual): 456
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 02447
    • Kyunghee University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2016
• Primary Completion (Actual): May 24, 2017
• Study Completion (Actual): September 26, 2017

Study Registration Dates

• First Submitted: April 21, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: YH23537-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No