Trial | NCT01873053  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    win34b ...

  • Study Participants

    150
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.

st group (experimental) : WIN-34B 450mg BID
nd group (experimental) : WIN-34B 900mg BID
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.
Study Started
Apr 30
2013
Primary Completion
Apr 30
2014
Study Completion
Aug 31
2014
Last Update
Nov 24
2015
Estimate

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

1st group : WIN-34B 900mg Experimental

Patients assigned to 1st group take WIN-34B 450mg BID for 12weeks

2nd group : WIN-34B 1800mg Experimental

Patients assigned to 2nd group take WIN-34B 900mg BID for 12weeks

3rd group : Placebo Placebo Comparator

Patients assigned to 3rd group take Placebo BID for 12weeks

Criteria 

Inclusion Criteria:

Being between 35 and 80 years of age
Diagnosed with Osteoarthritis of the knee at least 3 months
Diagnosed with Osteoarthritis of the knee, based on ACR criteria
Able to communicate with researchers and write questionnaires
At the screening visit, checking 100mm Pain VAS at least 80mm
At randomization(Visit 2), checking 100mm Pain VAS over 50mm
Agreeing to participate and signing informed consent voluntarily

Exclusion Criteria:

Previous intra-articular injection on knee within 3 months
Previous knee surgery within 6 months or scheduled procedures
Other diseases that could affect or interfere with the therapeutic outcomes
Experiencing habitual use of psychotropic, narcotic analgesic drugs over 1 week
Diagnosed with gastrointestinal diseases, unable to stop medicines during the study
At the screening visit, identified liver dysfunction
At the screening visit, identified renal dysfunction
Patients who cannot take NSAIDs
Pregnancy and breast-feeding (women of childbearing age need pregnancy test)
Physicological or mental disorders, including drug-takers
Orthopedic diseases that could affect or interfere with the therapeutic outcomes
Inappropriate for the study
No Results Posted