Osteoarthritis, KneePhase 3NCT05362851
Clinical Trial of YYC301 P3 for Treatment of Osteoarthritis of the Knee
A Phase 3 study testing YYC301-1 & YYC301-2 & YYC301-3 in people with Osteoarthritis, Knee, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- YYC301-1 & YYC301-2 & YYC301-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 692 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Nov 2021to 31 Mar 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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)
- Nutritional supplements, physical therapy and Korean herbal medicine for knee osteoarthritis and it pain within 2 weeks.
- Subjects who have to take anticoagulant drugs such as warfarin and coumarin during this clinical trial.
- Subjects who took MAO inhibitors within 14 days before the screening or needed to take these drugs during this clinical trials.
- Subjects with drug and opioid hypersensitivity and who have history.
- Subjects with sulfanilamide allergy and who have history.
- Subjects with asthmma, acute rhinitis, nasal polyp, angioedema, urticaria, allergic reaction to aspirin or any oher NSAIDs(incluing COX-2 inhibitors)
- Subjects with significant investigations - Hyperkalemia(Exceeded 5.5mmol/L)
- Subjects with severe liver dysfunction (ALT or AST of more than 3.0 times the upper limit of ULN and 1.5 tmines the upper limit of ULN)
- Subjects with severe renal impairment (Serum Creatine > 3x ULN).
- Subjects with active peptic ulcer and gastrointestinal bleeding.
- Severe blood disease (Agranulocytosis, aplastic anemia, hemolytic anemia, Thrombocytopenia, etc.).
- Subjects with Crohn's disease or inflammatory bowel disease such as ulcerative clitis.
- Subjects with congestive heart failure(NYHA 2-4)
- Subjects with severe ischaemic heart disease, peripheral artery disease and/or cerebrovascular disease.
- Subjects with genetic problesa such as galactose intolerance), lapp lactase deficiency or glucose-galactose malabsorption).
- Subjects with acute alcohol intoxification.
- Subjects who are addicted with took central nervous system drugs such as painkillers, sleeping pills, anti-anxiety medications, etc.
- Subjects with severe bronchopulmonary dysplasia.
- Subjects with head injury history of brain structure lesions which may be in danger of mental confusion.
- Subjects with epilepsy who are treated properly.
- Subjects who use Tramadol to cure for narcotic withdrawal.
- Subjects who took other clinical drugs more than once within 30 days before the clinical trial.
- Subjects suspected to be pregnant who don't agree with the clinical method which is permitted medically during clinical trial(Method of hormone contraception, IUD(Intrauterine device) or IUS(Intrauterine system)), tubal ligation, bilateral tubal ligation(condom, Diaphragm, etc).
- Pregnant woman and breastfeeding woman.
- Subjects who can increase risk due to clinical test and administraion of drugs or have severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of thest results.
- Any other ineligible condition at the direction of investigator that would be ineligible to participate the study.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
KyungHee University Medical Center
Seoul, Dongdaemun-gu /Kyung Hee Dae-ro 23, 02447
Kyoung Ho Yoon, Ph.D., 82-2-958-8374, kyoungho@khmc.or.kr
About this study
Official title: 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
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
- Conditions
- Osteoarthritis, Knee
- Being tested
- YYC301-1 & YYC301-2 & YYC301-3, YYC301 placebo & Celecoxib 200mg
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YYC301-1 & YYC301-2 & YYC301-3Drug
Also called YYC301-1: Tramadol 37.5Mg+ Celecoxib 200mg, YYC301-2: Tramadol 75mg+ Celecoxib 200mg, YYC301-3: Tramadol 150mg+ Celecoxib 200mg
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
YYC301 placebo & Celecoxib 200mgDrug
comparator medication
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: YYC301-1 & YYC301-2 & YYC301-3 |
| YYC301-1 placebo, YYC301-2 placebo, YYC301-3 placebo & Celecoxib | Active comparator | 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. Receives: Drug: YYC301 placebo & Celecoxib 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 13 weeks after randomization after administration of YYC301(Experimental drug).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start11 Nov 2021
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The purpose of this study is to investigate the efficacy and safety after administration of YYC301(Experimental) or Celecoxib(Comparator) in subjects with knee osteoarthritis in a state of uncontrolled pain who took Celecoxib(Cox-2 inhibitor).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 692 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CliPSBnC
- Responsible party
- Sponsor
- Investigators
- Kyoung Ho Yoon, Ph.D., Principal investigator, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362851
- Sponsor's protocol ID
- YYPCT_YYC301_301
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05362851
- Acronym / sponsor ID
- YYPCT_YYC301_301
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 692 participants (estimated)
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- CliPSBnC
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The purpose of this study is to investigate the efficacy and safety after administration of YYC301(Experimental) or Celecoxib(Comparator) in subjects with knee osteoarthritis in a state of uncontrolled pain who took Celecoxib(Cox-2 inhibitor).
| Arm | Type | Receives |
|---|---|---|
| YYC301-1, YYC301-2, YYC301-3 & Celecoxib placebo | Experimental | Drug: YYC301-1 & YYC301-2 & YYC301-3* 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 comparator | Drug: YYC301 placebo & Celecoxib 200mgConcomitant 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- 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.
Key exclusion criteria (41 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YYC301-1 & YYC301-2 & YYC301-3Also: YYC301-1: Tramadol 37.5Mg+ Celecoxib 200mg, YYC301-2: Tramadol 75mg+ Celecoxib 200mg, YYC301-3: Tramadol 150mg+ Celecoxib 200mgYYC301-1: 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 | Drug | YYC301-1, YYC301-2, YYC301-3 & Celecoxib placebo |
| YYC301 placebo & Celecoxib 200mgcomparator medication | Drug | YYC301-1 placebo, YYC301-2 placebo, YYC301-3 placebo & Celecoxib |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyoung Ho Yoon, Ph.D. principal investigator
Kyunghee University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YYC301-1 & YYC301-2 & YYC301-3 in people with Osteoarthritis, Knee, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soo Min Lee, bachelor (82-2-6202-7119, smlee@yypharm.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100mm Pain VAS (time frame: at 13 weeks after randomization after administration of YYC301(Experimental drug).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.