A 12 Week, Phase II Trial to Evaluate the Efficacy and Safety of WIN-34B in Patients With Osteoarthritis of the Knee
Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Kyunghee University Medical Center
Collaborators:
Hamsoa Pharmaceutical Co., Ltd. Kyung Hee University Hospital at Gangdong