A 12 week, phase II trial to evaluate the efficacy and safety of WIN-34B in patients with Osteoarthritis of the knee
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0000732
- Lead Sponsor
- Hamsoa Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
1) Being between 35 and 80 years of age
2) Diagnosised with Osteoarthritis of the knee at least 3 months
3) Diagnosised with Osteoarthritis of the knee, based on ACR criteria
4) Able to communicate with researchers and write questionnaire
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
1) Previous intra-articular injection on knee within 3 months
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) Diagnosised 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method KWOMAC(Korean Western Ontario and McMaster Universities Osteoarthritis Index)
- Secondary Outcome Measures
Name Time Method Pain VAS 100mm;KHAQ(Korean Health Assessment Questionnaire) ;LFI(Lequesne's Functional Index) ;Nine Point Scale ;Cold-Heat Questionnaire;Dose and Frequency of Rescue drug;Satety(Vital sign, Physical examination, Laboratory experiment, ECG, Adverse event Etc.)