- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02554552
Clinical Trial of YY1201 for Treatment of Osteoarthritis of the Knee
A Multicenter, Randomized, Double-blinded, Parallel, Placebo-controlled, Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of Intra-articular YY1201 Once in the Treatment of Patients With Osteoarthritis of the Knee
연구 개요
상세 설명
연구 유형
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Seoul, 대한민국
- Samsung Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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.
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: YY1201 2ml
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YY1201 2ml
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실험적: YY1201 3ml
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YY1201 2ml
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위약 비교기: Placebo 2ml
Phosphate buffered saline 2ml
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phosphate buffered saline 2ml
다른 이름들:
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위약 비교기: 위약 3ml
인산염 완충 식염수 3ml
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인산염 완충 식염수 3ml
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Variation of the Weight-bearing pain(100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline
기간: Week 4 and Week 12
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Week 4 and Week 12
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Variation of the KOOS scales on the 4, 12 weeks after administration in comparison with baseline
기간: Week 4 and Week 12
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Week 4 and Week 12
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Variation of the rest pain(100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline
기간: Week 4 and Week 12
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Week 4 and Week 12
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베이스라인과 비교하여 투여 4, 12주에 움직임 통증(100mm-VAS)
기간: 4주 및 12주
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4주 및 12주
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기준선으로 투여 후 4주, 12주에 대한 환자 전체 평가(100mm-VAS)
기간: 4주 및 12주
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4주 및 12주
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투여 후 4, 12주에 조사자 종합 평가(100mm-VAS)
기간: 4주 및 12주
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4주 및 12주
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기준선에서 투여 후 4, 12주까지 무릎 관절 부종의 변화
기간: 4주 및 12주
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4주 및 12주
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기준선에서 투여 후 4, 12주까지의 무릎 관절 압력에 대한 압통의 변화
기간: 4주 및 12주
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4주 및 12주
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Rate of change of the Range Of Motion(ROM) in the knee joint on 4, 12 weeks after administration with baseline
기간: Week 4 and Week 12
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Week 4 and Week 12
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4주차, 12주차의 구조 약물 수 및 총량 사용
기간: 4주 및 12주
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4주 및 12주
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베이스라인과 비교하여 12주 동안 체중 부하 통증의 반응률
기간: 12주차
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12주차
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기준선과 비교하여 12주 동안 OMERACT-OARSI의 응답률
기간: 12주차
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12주차
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공동 작업자 및 조사자
수사관
- 수석 연구원: Chul-Won Ha, M.D., Samsung Medical Center, Department of Internal Medicine
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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