Eight-week, Multi-centre, Dose-response, Double Blind, Placebo-controlled, Randomized, Parallel-group, PhaseⅡ Trial to Evaluate Efficacy and Safety of SI000413 in Patients With Knee Osteoarthritis
Overview
- Phase
- Phase 2
- Enrollment
- 152
- Locations
- 3
- Primary Endpoint
- K-WOMAC
Overview
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 prior to randomization. Among those who meet the inclusion criteria, only subjects recording visual analogue scale(VAS) of higher than 40mm(VAS range from 0mm(no pain) to 100mm(unbearable pain)) are enrolled in this study.
Subjects meeting screening criteria will be randomized to receive 8 weeks dosing of an active dose of SI000413 or placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Arms & Interventions
SI000413 400mg
tablet, SI000413 200mg bid
Intervention: SI000413 (Drug)
SI000413 600mg
tablet, SI000413 200mg tid
Intervention: SI000413 (Drug)
SI000413 800mg
SI000413 200mg, 2T bid
Intervention: SI000413 (Drug)
placebo
placebo 2T tid for 8 weeks
Intervention: microcrystalline cellulose (Drug)
Outcomes
Primary Outcomes
K-WOMAC
Time Frame: Visit 6(8 week), baseline
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 Outcomes
- knee pain intensity assessment(baseline, Visit 4(4 week), Visit 6(8 week))
- Global assessment(regarding to disease activity)(Visit 4(4 week), Visit 6(8 week))
- K-WOMAC each domain assessment(baseline, Visit 6(8 week))
- ESR & hs-CRP(baseline, Visit 4(4 week), Visit 6(8 week))