어린이의 설사를 동반한 과민성 대장 증후군 치료에서 엘룩사돌린의 치료 효과를 탐색하기 위한 연구
설사를 동반한 과민성 대장 증후군(IBS-D)이 있는 소아 참가자(6~17세)에서 엘룩사돌린의 안전성과 효능을 평가하기 위한 2상, 무작위, 이중 맹검, 위약 대조, 병렬 그룹, 용량 범위 연구(IBS-D)
The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in pediatric participants 6-17 years of age, to evaluate the pharmacokinetics of eluxadoline in pediatric participants with IBS-D, and to evaluate the safety and tolerability of eluxadoline in pediatric participants with IBS-D. Enrollment of 12-17 years old age group is closed, enrollment of the 6-11 years old age group will continue.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 장소
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North Holland
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Amsterdam, North Holland, 네덜란드, 1105 AZ
- Duplicate_Academisch Medisch Centrum /ID# 237117
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Wuppertal, 독일, 42283
- HELIOS Klinikum Wuppertal /ID# 237322
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Arkansas
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Hot Springs, Arkansas, 미국, 71913
- HealthStar Research of Hot Springs PLLC /ID# 234609
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Little Rock, Arkansas, 미국, 72212-4187
- Applied Research Center of Arkansas /ID# 238070
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California
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Corona, California, 미국, 92879
- Kindred Medical Institute, LLC /ID# 237368
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Garden Grove, California, 미국, 92845
- Duplicate_VVCRD Research /ID# 234606
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Paramount, California, 미국, 90723
- Duplicate_Center for Clinical Trials LLC /ID# 234630
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Florida
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Miami, Florida, 미국, 33130
- Sunrise Research Institute /ID# 237382
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Miami, Florida, 미국, 33155
- South Miami Medical & Research Group Inc. /ID# 234655
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Miami, Florida, 미국, 33165
- Valencia Medical & Research Center /ID# 234672
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Miami, Florida, 미국, 33174
- Florida Research Center, Inc. /ID# 236514
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Miami Lakes, Florida, 미국, 33016
- Duplicate_Wellness Clinical Research /ID# 237401
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Georgia
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Atlanta, Georgia, 미국, 30315
- Global Research Associates /ID# 234646
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Atlanta, Georgia, 미국, 30342
- Children's Ctr Digestive, US /ID# 237575
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Stockbridge, Georgia, 미국, 30281
- Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343
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Illinois
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Park Ridge, Illinois, 미국, 60068
- Advocate Children's Hospital-Park Ridge /ID# 235388
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Indiana University Health Riley Hospital for Children /ID# 235400
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Kentucky
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Lexington, Kentucky, 미국, 40517
- Michael W. Simon, MD, PSC /ID# 236517
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Maryland
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New Market, Maryland, 미국, 21774-6154
- Frederick County Pediatrics /ID# 234519
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Minnesota
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Minneapolis, Minnesota, 미국, 55413-2195
- MNGI Digestive Health, P. A. /ID# 238057
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New Jersey
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Marlton, New Jersey, 미국, 08053
- Celen Medical Group Corp - Marlton /ID# 234922
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73106
- IPS Research Company /ID# 237672
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104-4319
- Children's Hospital of Philadelphia - Main /ID# 234313
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Pittsburgh, Pennsylvania, 미국, 15236
- Preferred Primary Care Physicians, Inc. /ID# 236436
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Texas
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Fort Worth, Texas, 미국, 76104
- Cook Children's Med. Center /ID# 237537
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Houston, Texas, 미국, 77030-2608
- Texas Children's Hospital /ID# 238304
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San Antonio, Texas, 미국, 78215
- Sun Research Institute /ID# 236933
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West Virginia
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Morgantown, West Virginia, 미국, 26506
- West Virginia University Hospitals /ID# 256841
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Kozloduy, 불가리아, 3320
- MHATSv.Ivan Rilski /ID# 235399
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Plovdiv, 불가리아, 4001
- University Hospital Plovdiv /ID# 235450
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Gabrovo
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Sevlievo, Gabrovo, 불가리아, 5400
- Medical center 1 Sevlievo /ID# 237473
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Valencia, 스페인, 46017
- Hospital Universitario Dr. Peset /ID# 236755
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Blackpool, 영국, FY3 8NR
- Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273
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Greater London
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London, Greater London, 영국, SE5 9RS
- Kings College Hospital NHS Foundation Trust /ID# 236305
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Lancashire
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Manchester, Lancashire, 영국, M13 9WL
- Duplicate_Manchester University NHS Foundation Trust /ID# 234663
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Edmonton, 캐나다, T6G 1C9
- Duplicate_Edmonton Clinic Health Academy (ECHA) /ID# 234917
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Winnepeg, 캐나다, R3E 3P4
- Manitoba Institute of Child Health /ID# 235448
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, 폴란드, 30-539
- Specjalistyczne Gabinety Sp. z o.o. /ID# 236347
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, 폴란드, 00-189
- Centrum Zdrowia MDM /ID# 237269
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Warsaw, Masovian Voivodeship, 폴란드, 04-730
- Duplicate_Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311
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Podkarpackie Voivodeship
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Rzeszów, Podkarpackie Voivodeship, 폴란드, 35-302
- Korczowski Bartosz Gabinet Lekarski /ID# 234683
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, 폴란드, 80-803
- Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, 폴란드, 93-338
- Instytut Centrum Zdrowia Matki Polki /ID# 237438
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Budapest, 헝가리, 1125
- Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993
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Sopron, 헝가리, 9400
- Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341
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Székesfehérvár, 헝가리, 8000
- Vita Verum Medical Bt. /ID# 234321
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Participant must provide written or verbal informed assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures.
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Participant is a male or female outpatient, 6 to 17 years of age inclusive, at the time the participant provides assent for the study and parent/guardian/LAR has provided signed consent.
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Participant is able to read and understand the assessments in the eDiary. If the participant is 6 to 11 years of age and does not meet this criterion, the interviewer-administered version of the eDiary must be used and the parent/guardian/LAR or caregiver who will be administering the interviewer-administered version of the eDiary must be able to read and understand the assessments in the eDiary and must undergo training.
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Female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug. Female participants of childbearing potential must have a negative serum pregnancy test at Visit 1 (screening) and a negative urine pregnancy test at Visit 3 (randomization) prior to dosing.
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Female participants of childbearing potential must practice at least 1 protocol-specified method of birth control, that is effective from Study Day 1 through at least 30 days after the last dose of study drug. Local practices may require 2 methods of birth control. Female participants of non-childbearing potential do not need to use birth control.
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Participant has a diagnosis of IBS-D as defined by the modified Rome IV child/adolescent criteria: Must include all of the following:
-- Abdominal pain at least 4 days per month over at least 2 months associated with one or more of the following:
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Related to defecation
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A change in frequency of stool
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A change in form (appearance) of stool
- After appropriate evaluation, the symptoms cannot be fully explained by another medical condition.
- Participant has predominantly diarrheal stool symptoms defined as Bristol stool types 6 or 7 for more than 25% of bowel movements and Bristol stool types 1 or 2 for less than 25% of bowel movements that occur in the absence of laxative.
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Participant may be newly diagnosed with IBS-D by the investigator at Visit 1. All criteria for diagnosis must be fulfilled for at least 2 months prior to Visit 1 (screening).
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Participant has been compliant with the eDiary by completing both the morning and evening assessments for at least 8 out of the 14 days immediately preceding Visit 3 (randomization).
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Participant has an average daytime abdominal pain score greater than or equal to 1.0 over the 2 weeks prior to randomization.
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Participant has at least 1 daytime bowel movement with a consistency of Type 6 or Type 7 on the pediatric Bristol Stool Form Scale (p-BSFS) on at least 2 days per week during the 2 weeks immediately prior to randomization and that occurs in the absence of laxatives.
Exclusion Criteria:
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Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy).
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Participant has had any of the following surgeries:
- Any abdominal surgery within the 3 months prior to Screening; or
- A history of major gastric, hepatic, pancreatic, or intestinal surgery. (Note: appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed. For the purposes of this study, laparoscopic surgeries without complication are considered minor and non-exclusionary, provided the condition for which the surgery was performed was not exclusionary.)
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Participant has a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical GI obstruction or pseudo obstruction.
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Participant has a history or current diagnosis of constipation with encopresis.
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Participant meets the child/adolescent Rome IV criteria of IBS with constipation, IBS with constipation and diarrhea (mixed), unspecified IBS, or functional constipation.
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Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation.
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Participant has a documented history of hepatic impairment as defined by Child-Pugh Classification Grade A, B or C.
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Participant has a history or current diagnosis of inflammatory or immune-mediated lower GI disorders including inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, microscopic colitis). Crohn's disease affecting the upper GI tract would also be exclusionary.
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Participant has celiac disease, or a positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy.
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Participant has any congenital and/or acquired malabsorption syndrome (eg, Shwachman-Diamond syndrome).
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Participant has a history of a microbiologically documented (ie, stool culture or medical history) GI infection within 3 months prior to Screening.
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Participant has a known lactose or fructose intolerance that is associated with diarrhea, abdominal pain or discomfort, and that could confound assessments in the study.
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Participant has a history of diverticulitis within 3 months prior to Screening.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Eluxadoline 25mg
Eluxadoline 25mg, oral administration, twice daily |
Oral tablets
다른 이름들:
|
|
실험적: Eluxadoline 50mg
Eluxadoline 50mg, oral administration, twice daily |
Oral tablets
다른 이름들:
|
|
실험적: Eluxadoline 100mg
Eluxadoline 100mg, oral administration, twice daily |
Oral tablets
다른 이름들:
|
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실험적: Placebo
Dose-matched placebo, oral administration, twice daily |
Oral tablets |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in stool consistency averaged over the 4-week Treatment Period
기간: Baseline (2 Weeks prior to randomization) to Week 4
|
Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery). |
Baseline (2 Weeks prior to randomization) to Week 4
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in stool consistency for daily daytime and nighttime stool consistency scores
기간: Baseline (2 Weeks prior to randomization) to Week 4
|
Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery). |
Baseline (2 Weeks prior to randomization) to Week 4
|
|
Change from baseline for daytime, nighttime, and 24-hour abdominal pain scores
기간: Baseline (2 Weeks prior to randomization) to Week 4
|
Abdominal Pain is scored on a five-point ordinal scale, with 0 meaning no pain, and 4 meaning a lot of pain. |
Baseline (2 Weeks prior to randomization) to Week 4
|
|
Change from baseline for daytime, nighttime, and 24-hour bowel movement frequency
기간: Baseline (2 Weeks prior to randomization) to Week 4
|
Change from baseline in the number of bowel movements. |
Baseline (2 Weeks prior to randomization) to Week 4
|
|
Change from baseline for daytime, nighttime, and 24 hour urgency-free days
기간: Baseline (2 Weeks prior to randomization) to Week 4
|
Change from baseline in the number of urgency free days in a week. |
Baseline (2 Weeks prior to randomization) to Week 4
|
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Change from baseline for daytime, nighttime, and 24 hour number of fecal incontinence-free days
기간: Baseline (2 Weeks prior to randomization) to Week 4
|
Change from baseline in the number of fecal incontinence-free days in a week. |
Baseline (2 Weeks prior to randomization) to Week 4
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: ABBVIE INC., AbbVie
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 3030-202-002
- 2017 (미국 NIH 보조금/계약)
- 2017-003770-14 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
IPD 공유 기간
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD 공유 액세스 기준
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .