NCT02554240

Study to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients With Osteoarthritis of the Knee

Active-controlled, Dose-Response, Randomized, Double-blind, Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of Intra-articular DA-5202 in Patients With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This Phase II clinical study is to evaluate the efficacy and safety of DA-5202 in patients with osteoarthritis of the knee.

Detailed description

Eligible subjects are randomly assigned to receive DA-5202 high dose(20mg) or DA-5202 low dose(10mg) or Na Hyaluronate once a week intra-articular injection for 3 weeks.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	DA-5202 20mg	once a week, intra-articular injection, for 3 weeks
DRUG	DA-5202 10mg	once a week, intra-articular injection, for 3 weeks
DRUG	Na Hyaluronate 20mg	once a week, intra-articular injection, for 3 weeks

Timeline

• Start date: 2014-12-23
• Primary completion: 2016-06-29
• Completion: 2016-10-14
• First posted: 2015-09-18
• Last updated: 2021-04-14

Locations

1 site across 1 country: South Korea