Status:
COMPLETED
A 12 Week, Phase II Trial to Evaluate the Efficacy and Safety of WIN-34B in Patients With Osteoarthritis of the Knee
Lead Sponsor:
Kyunghee University Medical Center
Collaborating Sponsors:
Kyung Hee University Hospital at Gangdong
Hamsoa Pharmaceutical Co., Ltd.
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
35-80 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01873053
Start Date
April 1 2013
End Date
August 1 2014
Last Update
November 24 2015
Active Locations (1)
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1
Kyung Hee University Oriental Medicine Hospital at Gangdong
Seoul, South Korea, 134-727