A Clinical Trial of YH23537 in Patients With Knee Osteoarthritis

Yuhan

Status and phase: Completed; Phase 2

Conditions: Knee Osteoarthritis

Treatments: Drug: YH23537; Drug: YH23537 placebo; Drug: Celecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02759198

YH23537-202

Details and patient eligibility

About

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

Enrollment: 456 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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456 participants in 3 patient groups, including a placebo group

YH23537

Experimental group

Description:

YH23537 750/1500/3000mg

Treatment:

Drug: YH23537

Celebrex

Active Comparator group

Description:

Celecoxib 200mg

Treatment:

Drug: Celecoxib

Placebo

Placebo Comparator group

Description:

YH23537 Placebo

Treatment:

Drug: YH23537 placebo