- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02680847
Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain
2018년 8월 27일 업데이트: Pfizer
An Open-label Study To Evaluate The Pharmacokinetics And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Children And Adolescents 7-17 Years Of Age Who Require Opioid Analgesia
Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of oxycodone hydrochloride with a sequestered naltrexone core in children 7-17 with moderate-severe pain.
연구 개요
상세 설명
This is a multicenter, open-label, single-arm study designed to characterize the PK and to evaluate the safety of ALO-02 in children and adolescents 7 to 17 years of age who require opioid analgesia for moderate-to-severe pain.
The study consists of 4 study periods (screening, titration, maintenance, follow-up) occurring over a period of up to 9 weeks.
The study will enroll approximately 140 children and adolescents with at least 100 subjects once stabilized during the titration period to complete a minimum of 2 of the 4 weeks study duration in the maintenance period to satisfy the PK endpoint.
A safety follow-up visit is required at 1 week post-last dose.
연구 유형
중재적
등록 (실제)
32
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Lancaster, California, 미국, 93534
- Research Center For Clinical Studies-West, Inc.
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Los Angeles, California, 미국, 90027
- Children's Hospital of Los Angeles - University of Southern California School of Medicine
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Los Angeles, California, 미국, 90027
- Children's Hopsital Los Angeles
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Sacramento, California, 미국, 95817
- University of California Davis
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Sacramento, California, 미국, 95817
- Shriners Hospitals For Children Northern California
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Sacramento, California, 미국, 95817
- UC Davis Health Attn: Peter Trovitch, PharmD
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Illinois
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Chicago, Illinois, 미국, 60612
- University of Illinois at Chicago Clinical Research Center
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Chicago, Illinois, 미국, 60612
- University of Illinois Hospital and Health Sciences Systems
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Chicago, Illinois, 미국, 60612
- University of Illinois Hospital at the Medical Center
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North Carolina
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Greenville, North Carolina, 미국, 27834
- Leo Jenkins Cancer Center Pharmacy
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Greenville, North Carolina, 미국, 27834
- East Carolina University Brody School of Medicine(ECU)
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South Carolina
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Charleston, South Carolina, 미국, 29425
- Medical University of South Carolina Children's Hospital
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Charleston, South Carolina, 미국, 29425
- Medical University of South Carolina, SCTR Research Nexus
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Charleston, South Carolina, 미국, 29425
- Medical University of South Carolina, Investigational Drugs Services
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Charleston, South Carolina, 미국, 29425
- Medical University of South Carolina, Rutledge Tower, Pediatric Clinic
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Texas
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San Antonio, Texas, 미국, 78249
- Road Runner Research, Ltd
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
7년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Children 7-17 with moderate to severe pain requiring around the clock treatment with an opioid analgesic.
- Be an experienced opioid user, defined as any subject treated with opioid therapy, equivalent or equal to > 6 mg per day of oxycodone, for a period of 3 consecutive days immediately prior to first day of dosing.
Exclusion Criteria:
- Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation and behavior in past year.
- Hypersensitivity to morphine, naltrexone.
- A life expectancy (assessed by investigator) of less than 6 months or is no longer capable of taking medication orally.
- Undergone surgery within 3 days prior to the first day of dosing.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: ALO-02
One arm, open label, active
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Oral/Capsule, twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 4 week Maintenance Treatment duration.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Average Steady-state Concentration (Css, av) of Oxycodone
기간: Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
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ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl.
Oxycodone is a main component of this product.
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Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
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Apparent Oral Clearance (CL/F) of Oxycodone
기간: Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
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ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl.
Oxycodone is a main component of this product.
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Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
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Number of Participants With All-causality and Treatment-related Adverse Events (AEs)
기간: Baseline up to Day 63
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An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage.
All-causality AEs refer to any AE occurrence which needed not necessarily have a causal relationship with the treatment or usage.
Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage.
The majority of AEs were of mild to moderate severity.
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Baseline up to Day 63
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Number of All-causality and Treatment-related AEs, by Intensity
기간: Baseline up to Day 63
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An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage.
All-causality AEs refer to any AE occurrence which needed not necessarily have a causal relationship with the treatment or usage.
Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage.
The majority of AEs were of mild to moderate severity.
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Baseline up to Day 63
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Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs)
기간: Baseline up to Day 63
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An SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.
All-causality SAEs refer to any SAE occurrence which needed not necessarily have a causal relationship with the treatment or usage.
Treatment-related SAEs refer to SAEs that have a causal relationship with the treatment or usage.
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Baseline up to Day 63
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Number of Participants With Clinical Opiate Withdrawal Scale (COWS)
기간: Screening, Day 1, Titration Phase: Weeks 1,2,3,4; end of titration phase; Maintenance phase: Weeks 2, 4; early termination at titration phase, end of maintenance phase.
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The COWS contains 11 common opiate withdrawal signs or symptoms rated by the clinician.The summed score of the 11 items is used to assess a subject's level of withdrawal.
A subject assessed with a COWS score>= 13 was treated for opiate withdrawal signs and symptoms according to the investigator's medical judgment.
The total COWS score ranges from 0 to 48.
Higher scores indicate worse outcome.
Different score ranges represent different severities of withdrawal: no withdrawal (<5), mild (5-12), moderate (13-24), moderately severe (25-36), and severe (>36)
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Screening, Day 1, Titration Phase: Weeks 1,2,3,4; end of titration phase; Maintenance phase: Weeks 2, 4; early termination at titration phase, end of maintenance phase.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Apparent Volume of Distribution (Vz/F) of Oxycodone
기간: Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
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ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl.
Oxycodone is a main component of this product.
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Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
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Systemic Exposure Levels of the Metabolites of Oxycodone (Oxymorphone and Noroxycodone), Naltrexone, and 6-β-naltrexol.
기간: Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
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Oxymorphone and noroxycodone are major metabolites of Oxycodone and 6-β-naltrexol is the major metabolite of naltrexol.
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Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase
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Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria
기간: Baseline up to Day 58
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Following parameters were analyzed for examinations of vital signs: resting systolic and diastolic blood pressure, heart rate, and respiratory rate.
In this study, there were only participants meeting the maximum decrease from baseline in systolic blood pressure (SBP) >= 30 mmHg and diastolic blood pressure (DBP) >=20 mmHg criteria.
None of the vital sign changes were clinically significant.
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Baseline up to Day 58
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Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry)
기간: Baseline up to Day 77
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Following parameters were analyzed for hematologic laboratory tests: hemoglobin, hematocrit, red blood cells, mean corpuscular volume, platelets, white blood cells, lymphocytes (absolute & %), neutrophils (absolute & %), basophils (absolute & %), eosinophils (absolute &%), monocytes (absolute & %).
Following parameters were analyzed for chemical laboratory tests: bilirubin,aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase, protein(total), albumin,blood urea nitrogen, creatinine, cholesterol, sodium, potassium,chloride, calcium, phosphate, bicarbonate, glucose, creatine kinase.
None of the lab abnormalities were clinically significant.
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Baseline up to Day 77
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 1월 21일
기본 완료 (실제)
2018년 1월 10일
연구 완료 (실제)
2018년 1월 24일
연구 등록 날짜
최초 제출
2016년 1월 20일
QC 기준을 충족하는 최초 제출
2016년 2월 9일
처음 게시됨 (추정)
2016년 2월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 9월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 8월 27일
마지막으로 확인됨
2018년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- B4531015
- ALO-02 PHASE 4 PEDIATRIC STUDY (기타 식별자: Alias Study Number)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
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. .
ALO-02에 대한 임상 시험
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Tceleron Therapeutics, Inc.종료됨
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Translational Research Center for Medical Innovation...종료됨원발성 트리글리세라이드 침착성 심근혈관병증(TGCV) | 근병증을 동반한 중성 지질 축적병(NLSD-M)이탈리아, 일본
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Attralus, Inc.Novotech (Australia) Pty Limited모병