a Multicenter, Double-blind, Randomized, Active Drug Control, Parallel Design Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of YYC301 in Patients With Osteoarthritis of the Knee Joint
Overview
- Phase
- Phase 3
- Intervention
- YYC301-1 & YYC301-2 & YYC301-3
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- Enrollment
- 692
- Locations
- 1
- Primary Endpoint
- 100mm Pain VAS
- Last Updated
- 3 years ago
Overview
Brief Summary
A Multi-center, Double-blinded, Randomized, Active-controlled, Parallel Design, phase 3 Clinical Trial to Evaluate the Efficacy and Safety of YYC301 in Patients with Osteoarthritis of the Knee Joint
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men/Women aged over 20
- •Subjects who are diagnosed with one- or both-sided knee osteoarthritis according to the standards of clinical diagnosis from American College of Rheumatology(ACR)have knee osteoarthritis pain and meet over three of the following conditions.
- •Older than 50
- •Morning stiffness for less than 30 minutes
- •Crepitus on active motion
- •Bony tenderness
- •Bony enlargement
- •Not have heat-generating site
- •Subjects who are diagnosed with degenerative osteoarthritis and have its pain at least for over 3 months before the screening visit.
- •Subjects who are uncontrolled with pain after administration of Celecoxib at least for over 2 weeks before the randomization and have more than 50mm out of 100mm VAS at randomization.
Exclusion Criteria
- •Subjects with rheumatoid arthritis or inflammatory, infectiousand metabolic arthritis.
- •Subjects with ochronosis, hemochromatosis, secondary knee osteoarthritis by systemic disease.
- •Subjects who have severe pain such as Sudek's atrophy, Paget's disease and spinal disc herniation.
- •Subjects with poly-articular affected by severe pain of knee osteoarthritis.
- •Subjects who take psychtrophic medicine and narcotic analgesics for over 3 months that might affect on pain sensory system.
- •Subjects who had Tramadol but there was no improvement in pain.
- •Subjects who got the follwing treatment and medicine before the screening;
- •Subjects who had surgery on knee ligaments within a year, cartilage transplant and scarf osteotomy.
- •Subjects who had arthroscopy within 6 months.
- •Subjects with intra-articular knee joint steroid injection within 3 months.
Arms & Interventions
YYC301-1, YYC301-2, YYC301-3 & Celecoxib placebo
* YYC301-1 is a capsule. It is composed of Celecoxib 200mg and Tramadol 37.5mg complex. * YYC301-2 is a capsule. It is composed of Celecoxib 200mg and Tramadol 75mg complex. * YYC301-3 is a capsule. It is composed of Celecoxib 200mg and Tramadol 150mg complex.
Intervention: YYC301-1 & YYC301-2 & YYC301-3
YYC301-1 placebo, YYC301-2 placebo, YYC301-3 placebo & Celecoxib
Concomitant Drugs with Celecoxib 200mg and YYC301-1 placebo one capsule. Concomitant Drugs with Celecoxib 200mg and YYC301-2 placebo one capsule. Concomitant Drugs with Celecoxib 200mg and YYC301-3 placebo one capsule.
Intervention: YYC301 placebo & Celecoxib 200mg
Outcomes
Primary Outcomes
100mm Pain VAS
Time Frame: at 13 weeks after randomization after administration of YYC301(Experimental drug).
Subjects who have severe pain at one-or both sided knee osteoarthritis directly assess the degree of pain (within 24 hours) with a straight line which has 0mm to 100mm. 0 mm means 'doesn't have pain' and 100 mm means 'maximum pain who can imagine'.In order to investigate the degree of subject's pain change from administration of YYC301(Experimental drug).