None listed
Conditions
Interventions
Drug : Drug: SI000413
1 Tablet = 200mg, (400mg, 600mg or 800mg vs. placebo) for 8weeks
Arms: SI000413 400mg, SI000413 600mg, SI000413 800mg
Other Names:
SI000413
Drug: microcrystalline cellulose
Sponsors
Dong-A Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Males and females, 35-75 years old 2.Subjects must have a clinical or radiographic diagnosis of primary OA of the knee (diagnosed according to the ACR) a.The presence of knee pain b.At least one of the following - age older than 50 years - morning stiffness lasting less than 30 minutes - crepitus with motion c. osteophyte by radiography 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
Exclusion criteria: 1.Subjects who are not using adequate birth control. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the change in the sum of the K-WOMAC OA index at Visit 6(8 weeks) vs. baseline(Visit 2, 0 week). | — |
Secondary
| Measure | Time frame |
|---|---|
| The change from baseline to each day(4 week and 8 week). Subjects assess knee pain intensity by using 100mm VAS at each time;The change from Visit 4 to Visit 6 using 100mm VAS. Investigator assess by using 100mm VAS.;The change from Visit 4 to Visit 6 using 100mm VAS. Patient assess by using 100mm VAS.;The change from Visit 6(8 weeks) vs. baseline(Visit 2, 0 week) in the K-WOMAC each domain score. (K-WOMAC 3 domains: pain domain, stiffness domain, physical function domain);The change from baseline to each day(Visit 4, Visit 6) using laboratory test. | — |
Countries
Korea, Republic of
Contacts
Public ContactYeon Kim
KyungHee University Medical Center
Outcome results
None listed