Osteoarthritis, KneePhase 1/2NCT02965495
Clinical Trial of YYD302 for Treatment of Osteoarthritis of the Knee
A Phase 1/2 study testing YYD302 2ml and YYD302 3ml in people with Osteoarthritis, Knee, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This is a multicenter, randomized, double-blinded, parallel, placebo-controlled, phase I/IIa clinical trial of YYD302 for treatment of osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- YYD302 2ml and YYD302 3ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2016to Sep 2017
- Phase
- Phase 1/2
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or Females 40 years and older
- According to the clinical diagnosis standard of the American College of Rheumatology (ACR), someone, diagnosed as a single/both sides of osteoarthritis, who corresponds to over 3 conditions of followings.
- Over 50 years of age
- Less than 30 minutes of morning stiffness
- Crepitus on active motion
- 4 bony tenderness
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- Bony enlargement
- Nopalpable warmth of synvium
- Within 6 months from screening visit, someone who diagnosed with Kellgren \& Lawrence Grade I~III by the radioactive examination.
- By the Weight-bearing pain(100mm-VAS) examination, someone who has a outcome of the single or both sides of the osteoarthritis is over 40mm
- Patient (No-responder) who has experienced steady pain in spite of dosing NSAIDs or other pain-killers in the past.
- Patient who can walk by themselves without helper like cane or walker etc. (If the patient who has used helper routinely from previous 6 months, evaluating the patient including the helper is possible. In this case, patient needs to use same helper continuously by end of the clinical trial test.)
- Patient who agrees to participate in this clinical trial by themselves.
Who cannot join
- Someone who has BMI≥32kg/m² at the screening visit.
- Patient who has an experience dosing psychoactive drug, narcotic analgesic which can have an effect on pain sense over 3 months habitually.
- Patient who has been administrated gastrointestinal drug(for example H₂-blockers, misoprostol or proton pump inhibitors) regularly, who can't stop injecting for clinical study period.
- Patient has attended abnormal values from screening test(2 times excess at upper limit of the normal values at ALT, AST, BUN, Serum Creatinine).
- Patient who has rheumarthritis or other inflammatory metabolic arthritis.
- Patients having serious gastrointestinal, liver, renal, heart disease.
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- When the inflammatory disease is occurred on joint area to patient like septic arthritis.
- Patients having skin ailment at the injecting site of the joint region.
- Patients having secondary osteoarthritis according to the Ochronosis, Hemochromatosis or systemic disease.
- Patients who have severe pain like Sudek's atrophy, Paget's disease, Spinal disc herniation.
- Poly-articular patients who have suffered seriously by osteoarthritis at other parts affect judge of the knee joint pain.
- Patients who diagnosed clear interval disappearance at the knee joint by X-ray.
- Patients who were administrated below drugs before baseline visit.
- Patients who were injected HA at the target knee joint in recent 9 months.
- Patients who were injected HA at other parts of the knee joint in recent 6 months.
- Patients who were injected steroids into the intra-articular knee joint.
- Patients who were administrated steroids systemically by the oral medication (But, except inhalation)
- Patients who have joint effusion trouble were judged as a positive by tests like Patella tap test.
- Patients who have target knee joint gotten surgical operation history including Arthroscopy within past one year (In case of having other side of knee joint or hip joint gotten surgical operation history, excepting the patients if there is possibility which can influence the target knee joint's appraisal.
- Patients who have an operation history about target knee joint.
- Patients who do the height weight aerobic exercise or anaerobic exercise.
- Patients who need to be administrated anticoagulant agent together(But, except 300mg daily dose aspirin)
- Patients who have hypersensitivity history about Investigational Product.
- In the midst of women in their childbearing years, patients who disagree to do * contraception by medically permitted method for 12 weeks from administrating investigational product.
- The contraception by medically permitted method: Condom, In case of using injection or insertion, In case of installing a intrauterine contraception device etc.
- Patients who were injected other investigational product over a time within 30 days before participated in this clinical trail.
- Besides that, the patients who have difficulty to be participated in this clinical trial continuously by Principle Investigator (PI)'s decision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blinded, Parallel, Placebo-controlled, Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of Intra-articular YYD302 Once in the Treatment of Patients With Osteoarthritis of the Knee
This is a multicenter, randomized, double-blinded, parallel, placebo-controlled, phase I/IIa clinical trial of YYD302 for treatment of osteoarthritis of the knee.
Read the detailed description
phase I/IIa clinical trial of YYD302 for treatment of osteoarthritis of the knee
- Conditions
- Osteoarthritis, Knee
- Being tested
- YYD302 2ml, YYD302 3ml, Placebo 3ml
- Keywords
- Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YYD302 2mlDrug
YYD302 2ml
YYD302 3mlDrug
YYD302 3ml
Placebo 3mlDrug
Also called Placebo comparator 1
phosphate buffered saline 3ml
| Study group | Role | What they receive |
|---|---|---|
| YYD302 2ml | Experimental | YYD302 2ml Receives: Drug: YYD302 2ml |
| YYD302 3ml | Experimental | YYD302 3ml Receives: Drug: YYD302 3ml |
| Placebo 3ml | Placebo comparator | Phosphate buffered saline 3ml Receives: Drug: Placebo 3ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change of the Weight-bearing pain(100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline
Measured: Change of the week 4 and 12 from baseline
Secondary outcomes (11)
Rate of change of the KOOS scales on the 4, 12 weeks after administration in comparison with baseline
Measured: Week 4 and Week 12
Rate of change of the rest pain(100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline
Measured: Week 4 and Week 12
Motion pain (100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline
Measured: Week 4 and Week 12
Patient global assessment (100mm-VAS) on the 4, 12 weeks after administration with baseline
Measured: Week 4 and Week 12
Investigator global assessment (100mm-VAS) on the 4, 12 weeks after administration
Measured: Week 4 and Week 12
Change of the swelling in the knee joint from baseline to 4, 12 weeks after administration
Measured: Week 4 and Week 12
Change of the tenderness on pressure in the knee joint from baseline to 4, 12 weeks after administration
Measured: Week 4 and Week 12
Variation of the Range Of Motion(ROM) in the knee joint on 4, 12 weeks after administration with baseline
Measured: Week 4 and Week 12
Use of rescue medication count and the total amount on 4, 12 weeks
Measured: Week 4 and Week 12
Response rate of the Weight-bearing pain on 12 weeks in comparison with baseline
Measured: Week 12
Response rate of the OMERACT-OARSI on 12 weeks in comparison with baseline
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2017
- Study completionSep 2017
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chul-Won Ha, M.D, Principal investigator, Samsung Medical Center, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965495
- Sponsor's protocol ID
- YY_YYD302_001/2a
- Status last verified
- Dec 2017
- First submitted
- 2 Nov 2016
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blinded, Parallel, Placebo-controlled, Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of Intra-articular YYD302 Once in the Treatment of Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02965495
- Acronym / sponsor ID
- YY_YYD302_001/2a
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 16 Nov 2016 (estimated)
- 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.
This is a multicenter, randomized, double-blinded, parallel, placebo-controlled, phase I/IIa clinical trial of YYD302 for treatment of osteoarthritis of the knee.
Detailed description
phase I/IIa clinical trial of YYD302 for treatment of osteoarthritis of the knee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YYD302 2ml | Experimental | Drug: YYD302 2mlYYD302 2ml |
| YYD302 3ml | Experimental | Drug: YYD302 3mlYYD302 3ml |
| Placebo 3ml | Placebo comparator | Drug: Placebo 3mlPhosphate buffered saline 3ml |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males or Females 40 years and older
- According to the clinical diagnosis standard of the American College of Rheumatology (ACR), someone, diagnosed as a single/both sides of osteoarthritis, who corresponds to over 3 conditions of followings.
- Within 6 months from screening visit, someone who diagnosed with Kellgren \& Lawrence Grade I~III by the radioactive examination.
- By the Weight-bearing pain(100mm-VAS) examination, someone who has a outcome of the single or both sides of the osteoarthritis is over 40mm
- Patient (No-responder) who has experienced steady pain in spite of dosing NSAIDs or other pain-killers in the past.
Key exclusion criteria (27 listed)
- Someone who has BMI≥32kg/m² at the screening visit.
- Patient who has an experience dosing psychoactive drug, narcotic analgesic which can have an effect on pain sense over 3 months habitually.
- Patient who has been administrated gastrointestinal drug(for example H₂-blockers, misoprostol or proton pump inhibitors) regularly, who can't stop injecting for clinical study period.
- Patient has attended abnormal values from screening test(2 times excess at upper limit of the normal values at ALT, AST, BUN, Serum Creatinine).
- Patient who has rheumarthritis or other inflammatory metabolic arthritis.
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 |
|---|---|---|
| YYD302 2mlYYD302 2ml | Drug | YYD302 2ml |
| YYD302 3mlYYD302 3ml | Drug | YYD302 3ml |
| Placebo 3mlAlso: Placebo comparator 1phosphate buffered saline 3ml | Drug | Placebo 3ml |
Primary outcome
Rate of change of the Weight-bearing pain(100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline
Time frame: Change of the week 4 and 12 from baseline
11 secondary outcomes
Rate of change of the KOOS scales on the 4, 12 weeks after administration in comparison with baseline
Time frame: Week 4 and Week 12
Rate of change of the rest pain(100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline
Time frame: Week 4 and Week 12
Motion pain (100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline
Time frame: Week 4 and Week 12
Patient global assessment (100mm-VAS) on the 4, 12 weeks after administration with baseline
Time frame: Week 4 and Week 12
Investigator global assessment (100mm-VAS) on the 4, 12 weeks after administration
Time frame: Week 4 and Week 12
Change of the swelling in the knee joint from baseline to 4, 12 weeks after administration
Time frame: Week 4 and Week 12
Change of the tenderness on pressure in the knee joint from baseline to 4, 12 weeks after administration
Time frame: Week 4 and Week 12
Variation of the Range Of Motion(ROM) in the knee joint on 4, 12 weeks after administration with baseline
Time frame: Week 4 and Week 12
Use of rescue medication count and the total amount on 4, 12 weeks
Time frame: Week 4 and Week 12
Response rate of the Weight-bearing pain on 12 weeks in comparison with baseline
Time frame: Week 12
Response rate of the OMERACT-OARSI on 12 weeks in comparison with baseline
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
- 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.
Chul-Won Ha, M.D principal investigator
Samsung Medical Center, Department of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing YYD302 2ml and YYD302 3ml 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 13 inclusion and 27 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 Dec 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Rate of change of the Weight-bearing pain(100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline (time frame: Change of the week 4 and 12 from baseline). 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 11 Dec 2017.