NCT01122485

Efficacy and Safety Study of PG201 Tablet in Patients With Osteoarthritis

For an 8-week, Single Center, Randomized, Double Blind, Placebo Controlled Exploratory Clinical Study to Assess the Efficacy, Dose Response and Safety of PG201 Tablet in Patients With Osteoarthritis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Helixmith Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to explore the efficacy, dose-response and safety of PG201 tablet in Korean patients with osteoarthritis.

Detailed description

In this study, the PG201 extract, the study drug, was administered twice daily after a meal to two investigational groups, the lower-dose group and the higher-dose group. The efficacy of each of dose group was compared to that of the control group to determine if there was a statistically significant difference between the investigational groups and the placebo group. In addition, the efficacy between the lower dose group and the high dose group was also compared to determine if there was a statistically significant difference.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
OTHER	PG201	two tablets
OTHER	Placebo	two tablets

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2010-05-13
• Last updated: 2025-09-25