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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

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

NCT ID

NCT02759198

First Posted

April 21, 2016

Last Updated

January 14, 2019

Sponsor

Yuhan Corporation

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

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

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

Learn more about this trial

A Clinical Trial of YH23537 in Patients With Knee Osteoarthritis

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