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Osteoarthritis, KneePhase 2NCT03850587

Clinical Trial of YYC301 for Treatment of Osteoarthritis of the Knee

A Phase 2 study testing Celecoxib 200mg, Tramadol 37.5Mg+ Celecoxib 200mg and Tramadol 75mg+ Celecoxib 200mg in people with Osteoarthritis, Knee, run by Yooyoung Pharmaceutical Co., Ltd. at 10 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A Multi-center, Double-blinded, Randomized, Active-controlled, Parallel Design, phaseII Study to Investigate the Efficacy and Safety of YYC301 in Subject With Knee Osteoarthritis 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?
Celecoxib 200mg, Tramadol 37.5Mg+ Celecoxib 200mg and Tramadol 75mg+ Celecoxib 200mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
261 participants
Where
10 sitesSouth Korea
Study dates
30 Aug 2018to 7 Sep 2020
Phase
Phase 2
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 40mm 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 2 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

10 sites in 1 country.

10 sites in 1 country

South Korea10 sites

  • Dong-A University Hospital.

    Busan

  • Bundang Seoul University Hospital

    Seoul

  • Gachon University Gil Medical Center

    Seoul

  • Gangnam Severance Hospital

    Seoul

  • Korea University Anam Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Kyung Hee University Hospital at Gangdong

    Seoul

  • KyungHee University Medical Center

    Seoul

  • Soonchungyand University Hospital

    Seoul

  • The Catholic University of Korea, Seoul ST. Mary's Hospital.

    Seoul

Other trials in South Korea

About this study

Official title: A Multi-center, Double-blinded, Randomized, Active-controlled, Parallel Design, phaseII Study to Investigate the Efficacy and Safety of YYC301 in Subject With Knee Osteoarthritis.

A Multi-center, Double-blinded, Randomized, Active-controlled, Parallel Design, phaseII Study to Investigate the Efficacy and Safety of YYC301 in Subject With Knee Osteoarthritis

Being tested
Celecoxib 200mg, Tramadol 37.5Mg+ Celecoxib 200mg, Tramadol 75mg+ Celecoxib 200mg, Tramadol 150mg+ 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.

  • Celecoxib 200mgDrug

    comparator medication

  • Tramadol 37.5Mg+ Celecoxib 200mgDrug

    Also called yyc301-1

    experimental medication

  • Tramadol 75mg+ Celecoxib 200mgDrug

    Also called yyc301-2

    experimental medication

  • Tramadol 150mg+ Celecoxib 200mgDrug

    Also called yyc301-3

    experimental medication

Study groups in NCT03850587
Study groupRoleWhat they receive
YYC301-1 & Celocoxib placeboExperimentalYYC301-1 one capsule and Concomitant Drug Celocoxib placebo. *YYC301-1 is a capsule. It is composed of Celocoxib 200mg and Tramadol 37.5mg complex).
Receives: Drug: Tramadol 37.5Mg+ Celecoxib 200mg
YYC301-2 & Celocoxib placeboExperimentalYYC301-2 one capsule and Concomitant Drug Celocoxib placebo. *YYC301-2 is a capsule. It is composed of Celocoxib 200mg and Tramadol 75mg complex)
Receives: Drug: Tramadol 75mg+ Celecoxib 200mg
YYC301-3 & Celocoxib placeboExperimentalYYC301-3 one capsule and Concomitant Drug Celocoxib placebo. *YYC301-3 is a capsule. It is composed of Celocoxib 200mg and Tramadol 150mg complex)
Receives: Drug: Tramadol 150mg+ Celecoxib 200mg
YYC301 placebo & CelecoxibActive comparatorConcomitant Drugs with Celecoxib 200mg and YYC301 one capsule.
Receives: Drug: Celecoxib 200mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: at 1,4,8,12 weeks after randomization after administration of YYC301(Experimental drug).

  2. KOOS(Knee Injury and Osteoarthritis Outcome Score)

    KOOS survey is consisted of total 42 questions at 5 groups. 7 questions about symptoms, 9 questions about pain, 17 questions about Function in daily,5 questions about function in sport and recreation(sport/Rec), 4 questions about the knee related quality of life(QoL). Subjects who are participated in this clinical trial, they directly assess these survey with 5 point Likert scale(0~4, 0 means 'nothing' and 4 means 'most severe') and KOOS results are converted to WOMAC score.

    Measured: at 4,8,12 weeks after randomization after administration of YYC301(Experimental drug).

  3. Patient Global Assessment(PGA)

    Subjects who have been admistrated YYC301 have to directly perform the patient global assessment with 5 point Likert Scale. It has 0 to 5 scales. 0 means 'very poor' and 5 means' very good' In order to investigate the Patient Global point assessment at specific weeks.

    Measured: at 4,8,12 weeks after randomization after administration of YYC301(Experimental drug).

  4. Total dosage and dosage rate of rescue treatment.

    Subjects who administration of YYC301(Experimental drug) are investigated total dosage and dosage rate of rescue treatment.

    Measured: at screening time(visit 1; 2 weeks before next visit 2), randomization(visit 2), 4, 8 weeks after randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2019
  2. Study start30 Aug 2018
  3. Primary completion12 May 2020
  4. Study completion7 Sep 2020

Resources

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 2
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
261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03850587
Sponsor's protocol ID
YYPCT_YYC301_P2
Status last verified
May 2021
First submitted
20 Feb 2019
Last updated
11 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Celecoxib 200mg, Tramadol 37.5Mg+ Celecoxib 200mg and Tramadol 75mg+ Celecoxib 200mg in people with Osteoarthritis, Knee, run by Yooyoung Pharmaceutical Co., Ltd. at 10 sites 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: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

100mm Pain VAS (time frame: at 1,4,8,12 weeks after randomization after administration of YYC301(Experimental drug).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03850587.

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 11 May 2021.

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