- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03731364
Study of CA-008 (Vocacapsaicin) in Total Knee Arthroplasty
A Phase 2, Randomized, Double-blind, Placebo-Controlled Efficacy, Pharmacokinetics and Safety Study of CA-008 (Vocacapsaicin) in Subjects Undergoing Total Knee Arthroplasty
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Texas
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Houston, Texas, 미국, 77402
- HD Research
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
- Plan to undergo an elective primary unilateral total knee arthroplasty (TKA or knee replacement), without collateral procedure or additional surgeries.
- Be a reasonably healthy adult aged 18 - 80 years old, inclusive, with a BMI ≤ 36 kg/m2 and American Society of Anesthesiology (ASA) physical Class 1, 2 or 3 at the time of randomization.
- Males and females must abstain from intercourse, use acceptable birth control methods or be sterile or otherwise incapable of having children.
- Be willing and able to sign the informed consent form (ICF)
- Be willing and able to complete study procedures and pain scales and to communicate meaningfully in English. Be able and willing to return for outpatient follow up visits as required.
Key Exclusion Criteria:
In the opinion of the Investigator,
- have a concurrent painful condition, other than pain in the knee to be replaced, that may require pain treatment during the study period.
- have active skin disease or other clinically significant abnormality at the anticipated site of surgery that could interfere with the planned surgery.
- Have a known allergy to chili peppers, capsaicin or the components of CA-008, ropivacaine, ketorolac, acetaminophen, fentanyl, hydromorphone, morphine or oxycodone.
- Have significant medical, neuropsychiatric or other condition.
The following are considered disallowed medications:
- tolerant to opioids as defined
- capsaicin-containing products or foods.
- central nervous system active agent as an analgesic adjunct medication
- antiarrhythmics except beta-blockers, digoxin, warfarin, lithium, or aminoglycosides or other antibiotics for an infection
- parenteral or oral corticosteroids.
- antianginal, antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days or which is not expected to remain stable while participating in the study.
- Have positive results on the alcohol breath/saliva test indicative of alcohol abuse or urine drug screen indicative of illicit drug use at screening, and/or prior to surgery.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: CA-008 5 mg (0.05 mg/mL) Cohort 1
Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008 (vocacapsaicin)
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5 mg CA-008 (0.05 mg/mL), 10 mg CA-008 (0.1 mg/mL) and 15 mg CA-008 (0.15 mg/mL)
다른 이름들:
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위약 비교기: Placebo - Cohort 1
Placebo for Cohort 1 Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active |
위약
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활성 비교기: CA-008 10 mg (0.1 mg/mL) Cohort 2
Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008 (vocacapsaicin)
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5 mg CA-008 (0.05 mg/mL), 10 mg CA-008 (0.1 mg/mL) and 15 mg CA-008 (0.15 mg/mL)
다른 이름들:
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활성 비교기: CA-008 15 mg (0.15 mg/mL) Cohort 3
Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008 (vocacapsaicin)
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5 mg CA-008 (0.05 mg/mL), 10 mg CA-008 (0.1 mg/mL) and 15 mg CA-008 (0.15 mg/mL)
다른 이름들:
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위약 비교기: Placebo - Cohorts 2 and 3
Placebo - Cohorts 2 and 3 Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active |
위약
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time-specific Mean Pain Intensity Scores (NRS) at Time 96 Hours for CA-008 vs. Placebo
기간: At 96 hours
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Primary Efficacy Endpoint for the Pilot Stage.
Time-specific mean pain intensity scores at Time 96 hours for CA-008 vs. placebo based on a 10-point numerical rating scale (NRS) from 0-10 where 0 is no pain and 10 is the worst pain imaginable).
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At 96 hours
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CA-008 Dose vs. Placebo Comparison: Area Under the Curve (AUC) 0 to 96 Hours
기간: From 0 hours to 96 hours
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Primary Efficacy Endpoint for Stage 2. Area Under the Curve (AUC) of the NRS current pain intensity scores from Time 0 hours to 96 hours at rest (AUC0 to 96h) where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. • During the inpatient stay, NRS at rest beginning with the PACU admission may be assessed once the subject is awake. The maximum is an NRS score of 10 x all 96 hours = 960 NRS units*hrs; the minimum is 0 x 96h = 0 NRS units*hrs |
From 0 hours to 96 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Subjects Who do Not Require Opioids
기간: Time 0 hours to Time 96 hours: Opioid Free 0 hours to 96 hours
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Key Secondary Efficacy Endpoints for Stage 2. For each CA-008 dose vs. placebo comparison, percentage of subjects who do not require opioids.
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Time 0 hours to Time 96 hours: Opioid Free 0 hours to 96 hours
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Total Opioid Consumption (in Daily Oral Morphine Equivalents)
기간: OC from Time 0 hours to Time 96 hours: OC 0 hours to 96 hours
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Key Secondary Efficacy Endpoints for Stage 2. Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo
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OC from Time 0 hours to Time 96 hours: OC 0 hours to 96 hours
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공동 작업자 및 조사자
수사관
- 수석 연구원: Daneshvari Solanki, MD, First Surgical Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .
위약에 대한 임상 시험
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AJU Pharm Co., Ltd.OM Pharma SA모병
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University Hospital, Strasbourg, France모집하지 않고 적극적으로