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
Overview
- Phase
- Phase 2
- Intervention
- WIN-34B
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Kyunghee University Medical Center
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- KWOMAC(Korean Western Ontario and McMaster Universities Osteoarthritis Index)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
- 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.
Investigators
Park Dong-Suk
Professor
Kyunghee University Medical Center
Eligibility 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
Arms & Interventions
1st group : WIN-34B 900mg
Patients assigned to 1st group take WIN-34B 450mg BID for 12weeks
Intervention: WIN-34B
2nd group : WIN-34B 1800mg
Patients assigned to 2nd group take WIN-34B 900mg BID for 12weeks
Intervention: WIN-34B
3rd group : Placebo
Patients assigned to 3rd group take Placebo BID for 12weeks
Intervention: Placebo
Outcomes
Primary Outcomes
KWOMAC(Korean Western Ontario and McMaster Universities Osteoarthritis Index)
Time Frame: Changes from baseline at 4, 12, 16weeks
Secondary Outcomes
- 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)
- Pain VAS 100mm(Visit1(screening), Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks))
- LFI(Lequesne's Functional Index)(Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks))
- Dose and Frequency of Rescue drug(Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks))
- KHAQ(Korean Health Assessment Questionnaire)(Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks))
- Nine Point Scale(Visit5(12weeks))
- Cold-Heat Questionnaire(Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks))