이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

하위 연구 01A: 전이성 거세 저항성 전립선암(mCRPC) 참가자에 대한 MK-5684 기반 치료 조합 또는 MK-5684 단독의 안전성 및 유효성(MK-5684-01A)

2026년 11월 6일 업데이트: Merck Sharp & Dohme LLC

MK-5684-01A 하위 연구: 전이성 거세 저항성 전립선암 참가자를 대상으로 MK-5684 기반 치료 병용 또는 MK-5684 단독의 안전성과 효능을 평가하기 위한 MK-5684-U01 마스터 프로토콜의 1/2상 우산 하위 연구 (mCRPC)

Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01).

The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC.

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

220

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 뉴질랜드
      • Auckland, 뉴질랜드, 1023
        • Auckland City Hospital ( Site 1333)
  • 대만
      • Taichung, 대만, 404332
        • China Medical University Hospital ( Site 1703)
      • Taipei, 대만, 112
        • Taipei Veterans General Hospital ( Site 1701)
      • Taoyuan, 대만, 333
        • Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1702)
    • Kaohsiung
      • Kaohsiung Niao Sung Dist, Kaohsiung, 대만, 83301
        • Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1704)
  • 대한민국
      • Seoul, 대한민국, 03722
        • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1502)
      • Seoul, 대한민국, 06351
        • Samsung Medical Center-Division of Hematology/Oncology ( Site 1501)
    • Seoul
      • Songpagu, Seoul, 대한민국, 05505
        • Asan Medical Center-Oncology ( Site 1500)
  • 덴마크
    • Capital Region
      • Copenhagen, Capital Region, 덴마크, 2730
        • Herlev and Gentofte Hospital ( Site 0501)
    • North Denmark
      • Aalborg, North Denmark, 덴마크, 9000
        • Aalborg Universitetshospital, Syd ( Site 0503)
  • 독일
      • Berlin, 독일, 10117
        • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0800)
      • Hamburg, 독일, 20246
        • Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0804)
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, 독일, 69120
        • Universitaetsklinikum Heidelberg ( Site 0805)
      • Tübingen, Baden-Wurttemberg, 독일, 72076
        • Universitaetsklinikum Tuebingen-Urologie ( Site 0801)
    • Bavaria
      • Munich, Bavaria, 독일, 81675
        • klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0802)
  • 미국
    • California
      • La Jolla, California, 미국, 92037
        • UCSD Moores Cancer Center ( Site 0039)
      • Los Angeles, California, 미국, 90404
        • UCLA Hematology/Oncology - Santa Monica ( Site 0044)
    • Florida
      • Miami, Florida, 미국, 33136
        • University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051)
    • Maryland
      • Baltimore, Maryland, 미국, 21201
        • University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049)
    • New Jersey
      • New Brunswick, New Jersey, 미국, 08903-2681
        • Rutgers Cancer Institute of New Jersey ( Site 0033)
    • Ohio
      • Cleveland, Ohio, 미국, 44106
        • University Hospitals Cleveland Medical Center ( Site 0043)
    • Wisconsin
      • Milwaukee, Wisconsin, 미국, 53226
        • MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0020)
  • 스페인
      • Barcelona, 스페인, 08035
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1602)
      • Madrid, 스페인, 28007
        • Hospital General Universitario Gregorio Marañón ( Site 1601)
      • Madrid, 스페인, 28040
        • Hospital Clinico San Carlos-Oncology Department ( Site 1604)
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, 스페인, 08908
        • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 1603)
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, 스페인, 28034
        • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1600)
  • 아일랜드
      • Cork, 아일랜드, T12 DC4A
        • Cork University Hospital ( Site 0902)
      • Dublin, 아일랜드, D24 NR0A
        • Tallaght University Hospital ( Site 0900)
    • Dublin
      • Dublin, Dublin, 아일랜드, D04 T6F4
        • St. Vincent's University Hospital ( Site 0901)
  • 영국
      • Birmingham, 영국, B15 2TH
        • Queen Elizabeth Hospital Birmingham ( Site 1903)
    • Cambridgeshire
      • Cambridge, Cambridgeshire, 영국, CB2 2QQ
        • Addenbrooke's Hospital ( Site 1902)
    • Glasgow City
      • Glasgow, Glasgow City, 영국, G12 0YN
        • The Beatson West of Scotland Cancer Centre ( Site 1904)
    • Lancashire
      • Preston, Lancashire, 영국, PR2 9HT
        • Royal Preston Hospital-Lancashire Clinical Research Facility ( Site 1900)
    • London, City of
      • London, London, City of, 영국, NW1 2PG
        • University College London Hospital ( Site 1905)
  • 이스라엘
      • Haifa, 이스라엘, 3109601
        • Rambam Health Care Campus-Oncology Division ( Site 1002)
      • Petah Tikva, 이스라엘, 4941492
        • Rabin Medical Center ( Site 1001)
      • Ramat Gan, 이스라엘, 5265601
        • Sheba Medical Center ( Site 1000)
  • 이탈리아
      • Verona, 이탈리아, 37134
        • Azienda Ospedaliera Universitaria Integrata Verona - Ospedal-Centro Ricerche Cliniche di Verona ( Site 1100)
    • Lazio
      • Rome, Lazio, 이탈리아, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1102)
    • Lombardy
      • Milan, Lombardy, 이탈리아, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1103)
    • Milano
      • Rozzano, Milano, 이탈리아, 20089
        • Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1101)
  • 일본
      • Fukuoka, 일본, 812-8582
        • Kyushu University Hospital ( Site 1204)
    • Chiba
      • Sakura, Chiba, 일본, 285-8741
        • Toho University Sakura Medical Center ( Site 1201)
    • Kanagawa
      • Yokohama, Kanagawa, 일본, 232-0024
        • Yokohama City University Medical Center ( Site 1203)
    • Tokyo
      • Mitato, Tokyo, 일본, 105-8471
        • The Jikei University Hospital ( Site 1202)
  • 칠레
    • Biobio
      • Temuco, Biobio, 칠레, 4810218
        • CIDO SpA-Oncology ( Site 0302)
    • Maule Region
      • Talca, Maule Region, 칠레, 3465584
        • Clinica Universidad Catolica del Maule-Oncology ( Site 0304)
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, 칠레, 7500921
        • Fundación Arturo López Pérez ( Site 0301)
      • Santiago, Region M. de Santiago, 칠레, 832000
        • Pontificia Universidad Catolica de Chile ( Site 0303)
      • Santiago, Region M. de Santiago, 칠레, 8420383
        • Bradfordhill ( Site 0300)
  • 캐나다
    • Quebec
      • Montreal, Quebec, 캐나다, H2X 3E4
        • Centre Hospitalier de l'Université de Montréal ( Site 0200)
      • Montreal, Quebec, 캐나다, H3T 1E2
        • Jewish General Hospital ( Site 0206)
      • Québec, Quebec, 캐나다, G1J 1Z4
        • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0207)
  • 콜롬비아
    • Bogota D.C.
      • Bogotá, Bogota D.C., 콜롬비아, 110131
        • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0406)
      • Bogotá, Bogota D.C., 콜롬비아, 111321
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0402)
    • Cesar Department
      • Valledupar, Cesar Department, 콜롬비아, 200001
        • Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0400)
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, 콜롬비아, 230002
        • IMAT S.A.S ( Site 0404)
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, 콜롬비아, 760032
        • Fundación Valle del Lili-Oncology CIC ( Site 0403)
  • 터키 (Türkiye)
      • Adana, 터키 (Türkiye), 01250
        • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1802)
      • Ankara, 터키 (Türkiye), 06230
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 1800)
      • Ankara, 터키 (Türkiye), 06800
        • Ankara Bilkent Şehir Hastanesi ( Site 1801)
      • Istanbul, 터키 (Türkiye), 34668
        • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1804)
      • Istanbul, 터키 (Türkiye), 34722
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1803)
  • 폴란드
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 폴란드, 85-796
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1402)
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, 폴란드, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1400)
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, 폴란드, 80-952
        • Uniwersyteckie Centrum Kliniczne ( Site 1405)
  • 프랑스
      • Paris, 프랑스, 75015
        • Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0702)
    • Aquitaine
      • Bordeaux, Aquitaine, 프랑스, 33076
        • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0703)
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, 프랑스, 67200
        • Hopitaux Universitaires de Strasbourg ( Site 0700)
    • Île-de-France Region
      • Villejuif, Île-de-France Region, 프랑스, 94805
        • Gustave Roussy ( Site 0701)
  • 핀란드
    • Pohjanmaa
      • Vaasa, Pohjanmaa, 핀란드, 65130
        • Vaasan Keskussairaala ( Site 0603)
    • Uusimaa
      • Helsinki, Uusimaa, 핀란드, 00029
        • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0604)
      • Helsinki, Uusimaa, 핀란드, 00180
        • Docrates Syöpäsairaala ( Site 0602)
  • 호주
    • New South Wales
      • Macquarie University, New South Wales, 호주, 2109
        • Macquarie University-MQ Health Clinical Trials Unit ( Site 0108)
    • Queensland
      • Greenslopes, Queensland, 호주, 4120
        • Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107)
    • Victoria
      • Melbourne, Victoria, 호주, 3000
        • Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110)

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without small cell histology.
  • Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6 months before screening.
  • Evidence of disease progression from either, >4 weeks from last flutamide treatment, or >6 weeks from last bicalutamide or nilutamide treatment, if receiving first generation anti-androgen therapy as last treatment therapy.
  • Current evidence of metastatic disease.
  • Prior treatment with 1 to 2 novel hormonal agent(s) (NHA) for non-metastatic, or metastatic, hormone-sensitive prostate cancer or castration-resistant prostate cancer and have disease progression during or after treatment.
  • Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for >4 weeks before randomization.
  • Participants who experienced adverse events (AEs) due to previous anticancer therapies must have recovered to <Grade 1 or baseline.
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load.
  • Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • History of pituitary dysfunction.
  • Poorly controlled diabetes mellitus.
  • Active or unstable cardio/cerebro-vascular disease, including thromboembolic events and history of stroke or transient ischemic attack within 6 months before the first dose of study intervention, history of myocardial infarction within 6 months before the first dose of study intervention, New York Heart Association Class III or IV cardiac disease or congestive heart failure, coronary heart disease that is symptomatic, or unstable angina
  • History or family history of long corrected QT interval (QTc) syndrome.
  • Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or features suggestive of MDS/AML.
  • History or current condition of adrenal insufficiency.
  • History of (noninfectious) pneumonitis requiring steroids, or current pneumonitis.
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • Undergone major surgery, including local prostate intervention (except prostate biopsy) within 28 days before randomization, and has not recovered from the toxicities and/or complications.
  • Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study intervention.
  • Received a whole blood transfusion in the last 120 days before randomization (packed red blood cells and platelet transfusions are acceptable if not given within 28 days before randomization).
  • Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
  • Received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities, requiring corticosteroids.
  • Received a live or live-attenuated vaccine within 30 days before the first does of study intervention. Administration of killed vaccines is allowed.
  • Diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy, or any other form of immunosuppressive therapy, within 7 days prior to the first dose of study intervention.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Active autoimmune disease that has required systemic treatment in the past 2 years.
  • Active infection requiring systemic therapy.
  • Concurrent active HBV or HCV infections.

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
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Arm A1: Opevesostat

Participants receive 5 mg of opevesostat twice daily (BID) via oral tablet plus dexamethasone 1.5 mg by oral tablets once daily (QD) and 0.1 mg fludrocortisone acetate by oral tablet QD until progression or discontinuation.
의약품: Opevesostat

Oral Tablet

다른 이름들:
  • MK-5684
의약품: Fludrocortisone acetate

Oral Tablet

의약품: Dexamethasone

Oral Tablet
실험적: Arm A2: Olaparib + Opevesostat

Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 300 mg of olaparib BID via oral tablet until progressive disease or discontinuation.
의약품: Opevesostat

Oral Tablet

다른 이름들:
  • MK-5684
의약품: Fludrocortisone acetate

Oral Tablet

의약품: Dexamethasone

Oral Tablet

의약품: Olaparib

Oral Tablet

다른 이름들:
  • 린파자®
실험적: Arm A3: Docetaxel + Opevesostat

Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 75 mg/m^2 of docetaxel once every 3 weeks (Q3W) via IV infusion, plus prednisone per approved product label BID by oral tablets until progressive disease or discontinuation.
의약품: Docetaxel

IV Infusion

다른 이름들:
  • 탁소테레®
의약품: Opevesostat

Oral Tablet

다른 이름들:
  • MK-5684
의약품: Fludrocortisone acetate

Oral Tablet

의약품: Dexamethasone

Oral Tablet

의약품: Prednisone

Oral Tablet
실험적: Arm A4: Cabazitaxel + Opevesostat

Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 20 mg/m^2 of cabazitaxel Q3W via IV infusion, plus prednisone per approved product label BID by oral tablets until progressive disease or discontinuation.
의약품: Opevesostat

Oral Tablet

다른 이름들:
  • MK-5684
의약품: Fludrocortisone acetate

Oral Tablet

의약품: Dexamethasone

Oral Tablet

의약품: Prednisone

Oral Tablet

의약품: Cabazitaxel

IV Infusion

다른 이름들:
  • 제브타나®

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of participants who experience one or more dose-limiting toxicities (DLTs)
기간: Up to approximately 28 days

The following events, if considered drug related by the investigator, will be considered a DLT: Grade 4 nonhematologic toxicity (not laboratory value); Grade 4 hematologic toxicity lasting >7 days, except thrombocytopenia (Grade 4 thrombocytopenia of any duration, Grade 3 thrombocytopenia associated with clinically significant bleeding); Any nonhematologic adverse event (AE) >Grade 3 in severity should be considered a DLT (with exceptions); Any Grade 3 or Grade 4 nonhematologic laboratory value (if certain criteria are met); Febrile neutropenia Grade 3 or Grade 4; Prolonged delay (>2 weeks) in initiating treatment after the first 28 days due to study intervention-related toxicity; Missing >25% of study intervention doses as a result of drug-related AE(s) during the first 28 days; Grade 5 toxicity.
Up to approximately 28 days
Number of participants who experience one or more adverse events (AEs)
기간: Up to approximately 46 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 46 months
Number of participants who discontinue study intervention due to an AE
기간: Up to approximately 46 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 46 months
Prostate-specific antigen (PSA) response rate
기간: Up to approximately 46 months

The Prostate-specific Antigen (PSA) response rate is the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by ≥50%. The reduction in PSA level will be confirmed by an additional PSA evaluation performed ≥3 weeks from the original response per Prostate Cancer Working Group (PCWG) criteria.
Up to approximately 46 months

2차 결과 측정

결과 측정
측정값 설명
기간
Objective response rate (ORR)
기간: Up to approximately 46 months

The ORR is defined as the percentage of participants with complete response (CR: disappearance of all target lesions per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1); and no evidence of disease (NED) on base scan per Prostate Cancer Working Group (PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG). ORR will be assessed by Blinded Independent Central Review (BICR).
Up to approximately 46 months
Radiographic progression-free survival (rPFS)
기간: Up to approximately 46 months

rPFS is defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per modified RECIST 1.1 is ≥20% increase in the sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria is the appearance of ≥2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and are persistent for ≥6 weeks. rPFS will be assessed by BICR.
Up to approximately 46 months
Overall survival (OS)
기간: Up to approximately 46 months

OS is defined as the time from randomization to death due to any cause.
Up to approximately 46 months
Duration of response (DOR)
기간: Up to approximately 46 months

DOR is defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of a least 5 mm. PD per PCWG is the appearance of >2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and are persistent for >6 weeks. DOR will be assessed by BICR.
Up to approximately 46 months
Time to first subsequent anticancer therapy (TFST)
기간: Up to approximately 46 months

TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first.
Up to approximately 46 months
Time to pain progression (TTPP)
기간: Up to approximately 46 months

TTPP is defined as the time from randomization to pain progression based on the Brief Pain Inventory-Short Form (BPI-SF) Item 3 "worst pain in 24 hours" and by opiate analgesic use.
Up to approximately 46 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Merck Sharp & Dohme LLC

협력자

Orion Corporation, Orion Pharma

수사관

  • 연구 책임자: Medical Director, Merck Sharp & Dohme LLC

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

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)

2024년 5월 20일

기본 완료 (추정된)

2029년 1월 15일

연구 완료 (추정된)

2029년 1월 15일

연구 등록 날짜

최초 제출

2024년 4월 3일

QC 기준을 충족하는 최초 제출

2024년 4월 3일

처음 게시됨 (실제)

2024년 4월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 6일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 5684-01A
  • MK-5684-01A (기타 식별자: MSD)
  • U1111-1292-6912 (레지스트리 식별자: UTN)
  • jRCT2031240224 (레지스트리 식별자: Japan Registry of Clinical Trials (jRCT))
  • 2023-506288-33-00 (레지스트리 식별자: EU CT)
  • 2023 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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. .

구독하다