NCT04858659

A Phase 3 Study to Assess the Efficacy and Safety of PK101 in Patients With Knee Osteoarthritis

A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-designed, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of PK101 Compared With PK101-002 in Patients With Knee Osteoarthritis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (estimated)
• Sponsor: PMG Pharm Co., Ltd · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and the safety of PK101 in patients with knee osteoarthritis.

Detailed description

The primary purpose of this study is to evaluate the efficacy of PK101 compared with PK101-002 at Week 8 in osteoarthritis. Also evaluates the safety of PK101.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	PK101	1 tablet at each time, 2 times a day
DRUG	PK101-002	1 tablet at each time, 2 times a day
DRUG	PK101 placebo	1 tablet at each time, 2 times a day
DRUG	PK101-002 placebo	1 tablet at each time, 2 times a day

Timeline

• Start date: 2021-05-20
• Primary completion: 2022-03-15
• Completion: 2022-03-15
• First posted: 2021-04-26
• Last updated: 2021-09-22

Locations

1 site across 1 country: South Korea