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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: WIN-34B
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1st group : WIN-34B 900mg<br>Patients assigned to 1st group take WIN-34B 450mg BID for 12weeks | Drug: WIN-34B<br>* Patients assigned to Experimental group(1st or 2nd group) take WIN-34B 450mg or WIN-34B 900mg BID for 12weeks<br>|
| Experimental: 2nd group : WIN-34B 1800mg<br>Patients assigned to 2nd group take WIN-34B 900mg BID for 12weeks | Drug: WIN-34B<br>* Patients assigned to Experimental group(1st or 2nd group) take WIN-34B 450mg or WIN-34B 900mg BID for 12weeks<br>|
| Placebo Comparator: 3rd group : Placebo<br>Patients assigned to 3rd group take Placebo BID for 12weeks | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KWOMAC(Korean Western Ontario and McMaster Universities Osteoarthritis Index) |  | Changes from baseline at 4, 12, 16weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain VAS 100mm |  | Visit1(screening), Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks) | 
| KHAQ(Korean Health Assessment Questionnaire) |  | Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks) | 
| LFI(Lequesne's Functional Index) |  | Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks) | 
| Nine Point Scale |  | Visit5(12weeks) | 
| Cold-Heat Questionnaire |  | Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks) | 
| Dose and Frequency of Rescue drug |  | Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks) | 
| Safety(Vital sign, Physical examination, Laboratory experiment, ECG, Adverse event) |  | Visit1(screening), Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks) - There are some differences in subgroup at every visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Knee, WIN-34B