A 12 Week, Phase II Trial to Evaluate the Efficacy and Safety of WIN-34B in Patients With Osteoarthritis of the Knee
NCT ID: NCT01873053
Last Updated: 2015-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2013-04-30
2014-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1st group : WIN-34B 900mg
Patients assigned to 1st group take WIN-34B 450mg BID for 12weeks
WIN-34B
Patients assigned to Experimental group(1st or 2nd group) take WIN-34B 450mg or WIN-34B 900mg BID for 12weeks
2nd group : WIN-34B 1800mg
Patients assigned to 2nd group take WIN-34B 900mg BID for 12weeks
WIN-34B
Patients assigned to Experimental group(1st or 2nd group) take WIN-34B 450mg or WIN-34B 900mg BID for 12weeks
3rd group : Placebo
Patients assigned to 3rd group take Placebo BID for 12weeks
Placebo
Interventions
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WIN-34B
Patients assigned to Experimental group(1st or 2nd group) take WIN-34B 450mg or WIN-34B 900mg BID for 12weeks
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with Osteoarthritis of the knee at least 3 months
3. Diagnosed with Osteoarthritis of the knee, based on ACR criteria
4. Able to communicate with researchers and write questionnaires
5. At the screening visit, checking 100mm Pain VAS at least 80mm
6. At randomization(Visit 2), checking 100mm Pain VAS over 50mm
7. Agreeing to participate and signing informed consent voluntarily
Exclusion Criteria
2. Previous knee surgery within 6 months or scheduled procedures
3. Other diseases that could affect or interfere with the therapeutic outcomes
4. Experiencing habitual use of psychotropic, narcotic analgesic drugs over 1 week
5. Diagnosed with gastrointestinal diseases, unable to stop medicines during the study
6. At the screening visit, identified liver dysfunction
7. At the screening visit, identified renal dysfunction
8. Patients who cannot take NSAIDs
9. Pregnancy and breast-feeding (women of childbearing age need pregnancy test)
10. Physicological or mental disorders, including drug-takers
11. Orthopedic diseases that could affect or interfere with the therapeutic outcomes
12. Inappropriate for the study
35 Years
80 Years
ALL
No
Sponsors
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Kyung Hee University Hospital at Gangdong
OTHER
Hamsoa Pharmaceutical Co., Ltd.
INDUSTRY
Kyunghee University Medical Center
OTHER
Responsible Party
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Park Dong-Suk
Professor
Principal Investigators
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Dong-Suk Park
Role: PRINCIPAL_INVESTIGATOR
Kyung Hee University Hospital at Gangdong
Locations
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Kyung Hee University Oriental Medicine Hospital at Gangdong
Seoul, , South Korea
Countries
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Other Identifiers
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KR-KHNMC-OA02
Identifier Type: -
Identifier Source: org_study_id