A Clinical Trial of YH23537 in Patients With Knee Osteoarthritis

NCT ID: NCT02759198

Last Updated: 2019-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

456 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-02

Study Completion Date

2017-09-26

Brief Summary

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

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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YH23537

YH23537 750/1500/3000mg

Group Type EXPERIMENTAL

YH23537

Intervention Type DRUG

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

Celebrex

Celecoxib 200mg

Group Type ACTIVE_COMPARATOR

Celecoxib

Intervention Type DRUG

Drug: Celecoxib 200mg

Placebo

YH23537 Placebo

Group Type PLACEBO_COMPARATOR

YH23537 placebo

Intervention Type DRUG

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

Interventions

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YH23537

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

Intervention Type DRUG

Celecoxib

Drug: Celecoxib 200mg

Intervention Type DRUG

YH23537 placebo

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

Intervention Type DRUG

Other Intervention Names

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YH23537 750mg/1500mg/3000mg Celecoxib 200mg

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yoon Je Cho, M.D, Ph.D

Role: STUDY_CHAIR

Kyunghee University Medical Center

Locations

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KyungHee University Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YH23537-202

Identifier Type: -

Identifier Source: org_study_id

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