NCT01873053

A 12 Week, Phase II Trial to Evaluate the Efficacy and Safety of WIN-34B in Patients With Osteoarthritis of the Knee

A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase II Trial to Evaluate the Efficacy and Safety of WIN-34B in Patients With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Kyunghee University Medical Center · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This trial is a multi-center, randomized, double-blind, placebo-controlled, parallel, phase II clinical trial and aimed at osteoarthritis of the knee. Patients who signed informed consent voluntarily and eligible for this study are assigned randomly to one of 3 groups after 2 week-Washout period. 1. st group (experimental) : WIN-34B 450mg BID 2. nd group (experimental) : WIN-34B 900mg BID 3. rd group (Comparator) : Placebo BID Patients will take WIN-34B or Placebo BID for 12 weeks. Based on baseline, after 4 weeks(Visit 3) and 12 weeks(Visit 5), Researchers check patients' physical examination, questionnaire, laboratory experiment. After 8 weeks(Visit 4), researchers check adverse effects and current medication status via telephone interview. After 12 weeks(Visit 5) patients stop taking drugs and after 16 weeks(Visit 6) researchers check patients' physical examination, questionnaire, adverse effects and current medication status.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	WIN-34B	Patients assigned to Experimental group(1st or 2nd group) take WIN-34B 450mg or WIN-34B 900mg BID for 12weeks
DRUG	Placebo

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-04-01
• Completion: 2014-08-01
• First posted: 2013-06-07
• Last updated: 2015-11-24

Locations

1 site across 1 country: South Korea