Status:
UNKNOWN
Study of SI000413 in Knee Osteoarthritis Patients
Lead Sponsor:
Dong-A Pharmaceutical Co., Ltd.
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
35-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate efficacy and safety of SI000413 in patients with knee osteoarthritis by orally administration and to determine optimal dose.
Detailed Description
This is a dose-response, double blind , placebo-controlled study. All patients are required to have 2 weeks washout period from prior medication. Subjects will discontinue current medications 2 weeks ...
Eligibility Criteria
Inclusion
- Males and females, 35-75 years old
- Subjects must have a clinical or radiographic diagnosis of primary OA of the knee (diagnosed according to the ACR)
- The presence of knee pain
- At least one of the following
- age older than 50 years
- morning stiffness lasting less than 30 minutes
- crepitus with motion
- Subjects must have been symptomatic for at least 3 months prior to enrollment.
- Subjects must be required to have experienced a pain intensity of at least 40mm on a 100-mm visual analogue scale in the most severely affected joint during the 24 hours prior to randomization.
- Adequate liver and kidney function
- Adequate liver function : SGOT, SGPT must be within 1.5 x normal limit
- Adequate kidney function : Serum creatinine must be within 1.5 x normal limit
- Subjects must be able to read, understand and follow the study instructions
- Subjects must agree to informed consent spontaneously.
Exclusion
- Subjects who are not using adequate birth control.
- Pregnant or breast-feeding.
- Subjects requiring Knee surgery within 1 year of screening anticipating any need for a surgical procedure during the study.
- Secondary OA patients
- Similar OA patients(ex. rheumatic arthritis, bursitis etc)
- Treatment with intra-articular injections of systemic corticosteroids or hyaluronic acid in the prior 3 months.
- Use of drugs or psychotropic medicine(methadone maintenance program, codeine, tramadol hydrochloride)
- Anemia or coagulant disorder
- Use of anticoagulants or lithium
- Use of misoprostol or H2-blocker(including anti ulcer medicine)
- Presence or history of gastrointestinal bleeding within the past 1 year.
- Subjects who have serious problem with cardiovascular, respiratory, endocrine, central nervous or History of neurotic mental.
- Active malignancy of any type(ex. lymphoma, multiple myeloma etc)
- Use of any medication that will affect pain perception during the study period; physical therapy, corticosteroids, NSAIDs, asprin, topical analgesics.
- Use of glucosamine, chondroitin during the study period.
- Change of concomitant dose/use within 4 weeks.
- Known allergy or hypersensitivity to medicine.
- Subjects received hormone replacement therapy.
- Use of any other investigational drug within 1 month prior to screening.
- Investigators determines that it is not appropriate.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT01525758
Start Date
January 1 2012
End Date
December 1 2013
Last Update
August 13 2013
Active Locations (3)
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1
KyungHee University medical center
Seoul, Hoegi-dong, Dongdaemun-gu, South Korea, 130-872
2
Ajou University Medical Center
Gyeonggi-do, Woncheon-dong Yeongtong-gu, Suwon, South Korea, 443-721
3
Seoul National University Hospital
Seoul, Yongon-dong, Chongno-gu, South Korea, 110-744