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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UNKNOWN
PHASE2
152 participants
INTERVENTIONAL
2012-01-31
2013-12-31
Brief Summary
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Detailed Description
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Subjects meeting screening criteria will be randomized to receive 8 weeks dosing of an active dose of SI000413 or placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SI000413 400mg
tablet, SI000413 200mg bid
SI000413
1 Tablet = 200mg, (400mg, 600mg or 800mg vs. placebo) for 8weeks
SI000413 600mg
tablet, SI000413 200mg tid
SI000413
1 Tablet = 200mg, (400mg, 600mg or 800mg vs. placebo) for 8weeks
SI000413 800mg
SI000413 200mg, 2T bid
SI000413
1 Tablet = 200mg, (400mg, 600mg or 800mg vs. placebo) for 8weeks
placebo
placebo 2T tid for 8 weeks
microcrystalline cellulose
identical number of tablets to active drug groups
Interventions
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SI000413
1 Tablet = 200mg, (400mg, 600mg or 800mg vs. placebo) for 8weeks
microcrystalline cellulose
identical number of tablets to active drug groups
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
3. Subjects must have been symptomatic for at least 3 months prior to enrollment.
4. 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.
5. 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
6. Subjects must be able to read, understand and follow the study instructions
7. Subjects must agree to informed consent spontaneously.
Exclusion Criteria
2. Pregnant or breast-feeding.
3. Subjects requiring Knee surgery within 1 year of screening anticipating any need for a surgical procedure during the study.
4. Secondary OA patients
5. Similar OA patients(ex. rheumatic arthritis, bursitis etc)
6. Treatment with intra-articular injections of systemic corticosteroids or hyaluronic acid in the prior 3 months.
7. Use of drugs or psychotropic medicine(methadone maintenance program, codeine, tramadol hydrochloride)
8. Anemia or coagulant disorder
9. Use of anticoagulants or lithium
10. Use of misoprostol or H2-blocker(including anti ulcer medicine)
11. Presence or history of gastrointestinal bleeding within the past 1 year.
12. Subjects who have serious problem with cardiovascular, respiratory, endocrine, central nervous or History of neurotic mental.
13. Active malignancy of any type(ex. lymphoma, multiple myeloma etc)
14. Use of any medication that will affect pain perception during the study period; physical therapy, corticosteroids, NSAIDs, asprin, topical analgesics.
15. Use of glucosamine, chondroitin during the study period.
16. Change of concomitant dose/use within 4 weeks.
17. Known allergy or hypersensitivity to medicine.
18. Subjects received hormone replacement therapy.
19. Use of any other investigational drug within 1 month prior to screening.
20. Investigators determines that it is not appropriate.
35 Years
75 Years
ALL
No
Sponsors
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Dong-A Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yoon-Jae Cho, MD
Role: STUDY_CHAIR
Kyunghee University Medical Center
Myung-Chul Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
We-Yeon Won, MD
Role: PRINCIPAL_INVESTIGATOR
Ajou University Medical Center
Locations
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KyungHee University medical center
Seoul, Hoegi-dong, Dongdaemun-gu, South Korea
Ajou University Medical Center
Gyeonggi-do, Woncheon-dong Yeongtong-gu, Suwon, South Korea
Seoul National University Hospital
Seoul, Yongon-dong, Chongno-gu, South Korea
Countries
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Central Contacts
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Other Identifiers
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SI000413_OA_Ⅱ
Identifier Type: -
Identifier Source: org_study_id