Clinical Trial of YYC301 P3 for Treatment of Osteoarthritis of the Knee
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
1 other identifier
interventional
692
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2021
CompletedFirst Submitted
Initial submission to the registry
May 2, 2022
CompletedFirst Posted
Study publicly available on registry
May 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedMay 5, 2022
May 1, 2022
1.2 years
May 2, 2022
May 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
100mm Pain VAS
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).
at 13 weeks after randomization after administration of YYC301(Experimental drug).
Study Arms (2)
YYC301-1, YYC301-2, YYC301-3 & Celecoxib placebo
EXPERIMENTAL* 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.
YYC301-1 placebo, YYC301-2 placebo, YYC301-3 placebo & Celecoxib
ACTIVE COMPARATORConcomitant 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.
Interventions
YYC301-1: Subjects take the investigational products once a day YYC301-2: Subjects take the investigational products once a day YYC301-3: Subjects take the investigational products once a day
comparator medication
Eligibility Criteria
You may qualify if:
- 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.
- Subjects who voluntarily agree to participate in this clinical trial in writing.
You may not qualify if:
- 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.
- Subjects with HA injection in knee joint within 6 months.
- Subjects with systemic steroid injection within a month(but inhaled steroids)
- Subjects with knee replacement surgery.
- Subjects who hot the following treatment and medicine before the randomization;
- Subjects who had Celecoxib, acetaminophen or steroidal/non-steroidal anti-inflammatory drugs except low dose aspirin(before 300mg/day) But, acetaminophen and low dose aspirin (before 300mg/day) are prohibited within 24 hours)
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yooyoung Pharmaceutical Co., Ltd.lead
- CliPSBnCcollaborator
Study Sites (1)
KyungHee University Medical Center
Seoul, Dongdaemun-gu /Kyung Hee Dae-ro 23, 02447, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyoung Ho Yoon, Ph.D.
Kyunghee University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2022
First Posted
May 5, 2022
Study Start
November 11, 2021
Primary Completion
January 31, 2023
Study Completion
March 31, 2023
Last Updated
May 5, 2022
Record last verified: 2022-05