Studie zkoumající terapeutický účinek eluxadolinu při léčbě syndromu dráždivého tračníku s průjmem u dětí
Fáze 2, randomizovaná, dvojitě zaslepená, placebem kontrolovaná, paralelní skupinová studie s rozsahem dávek k vyhodnocení bezpečnosti a účinnosti eluxadolinu u pediatrických účastníků (ve věku 6 až 17 let) se syndromem dráždivého tračníku s průjmem (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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Kozloduy, Bulharsko, 3320
- MHATSv.Ivan Rilski /ID# 235399
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Plovdiv, Bulharsko, 4001
- University Hospital Plovdiv /ID# 235450
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Gabrovo
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Sevlievo, Gabrovo, Bulharsko, 5400
- Medical center 1 Sevlievo /ID# 237473
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North Holland
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Amsterdam, North Holland, Holandsko, 1105 AZ
- Duplicate_Academisch Medisch Centrum /ID# 237117
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Edmonton, Kanada, T6G 1C9
- Duplicate_Edmonton Clinic Health Academy (ECHA) /ID# 234917
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Winnepeg, Kanada, R3E 3P4
- Manitoba Institute of Child Health /ID# 235448
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Budapest, Maďarsko, 1125
- Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993
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Sopron, Maďarsko, 9400
- Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341
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Székesfehérvár, Maďarsko, 8000
- Vita Verum Medical Bt. /ID# 234321
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Wuppertal, Německo, 42283
- HELIOS Klinikum Wuppertal /ID# 237322
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polsko, 30-539
- Specjalistyczne Gabinety Sp. z o.o. /ID# 236347
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polsko, 00-189
- Centrum Zdrowia MDM /ID# 237269
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Warsaw, Masovian Voivodeship, Polsko, 04-730
- Duplicate_Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311
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Podkarpackie Voivodeship
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Rzeszów, Podkarpackie Voivodeship, Polsko, 35-302
- Korczowski Bartosz Gabinet Lekarski /ID# 234683
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polsko, 80-803
- Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, Polsko, 93-338
- Instytut Centrum Zdrowia Matki Polki /ID# 237438
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Blackpool, Spojené království, FY3 8NR
- Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273
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Greater London
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London, Greater London, Spojené království, SE5 9RS
- Kings College Hospital NHS Foundation Trust /ID# 236305
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Lancashire
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Manchester, Lancashire, Spojené království, M13 9WL
- Duplicate_Manchester University NHS Foundation Trust /ID# 234663
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Arkansas
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Hot Springs, Arkansas, Spojené státy, 71913
- HealthStar Research of Hot Springs PLLC /ID# 234609
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Little Rock, Arkansas, Spojené státy, 72212-4187
- Applied Research Center of Arkansas /ID# 238070
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California
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Corona, California, Spojené státy, 92879
- Kindred Medical Institute, LLC /ID# 237368
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Garden Grove, California, Spojené státy, 92845
- Duplicate_VVCRD Research /ID# 234606
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Paramount, California, Spojené státy, 90723
- Duplicate_Center for Clinical Trials LLC /ID# 234630
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Florida
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Miami, Florida, Spojené státy, 33130
- Sunrise Research Institute /ID# 237382
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Miami, Florida, Spojené státy, 33155
- South Miami Medical & Research Group Inc. /ID# 234655
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Miami, Florida, Spojené státy, 33165
- Valencia Medical & Research Center /ID# 234672
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Miami, Florida, Spojené státy, 33174
- Florida Research Center, Inc. /ID# 236514
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Miami Lakes, Florida, Spojené státy, 33016
- Duplicate_Wellness Clinical Research /ID# 237401
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Georgia
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Atlanta, Georgia, Spojené státy, 30315
- Global Research Associates /ID# 234646
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Atlanta, Georgia, Spojené státy, 30342
- Children's Ctr Digestive, US /ID# 237575
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Stockbridge, Georgia, Spojené státy, 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, Spojené státy, 60068
- Advocate Children's Hospital-Park Ridge /ID# 235388
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Indiana
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Indianapolis, Indiana, Spojené státy, 46202
- Indiana University Health Riley Hospital for Children /ID# 235400
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Kentucky
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Lexington, Kentucky, Spojené státy, 40517
- Michael W. Simon, MD, PSC /ID# 236517
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Maryland
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New Market, Maryland, Spojené státy, 21774-6154
- Frederick County Pediatrics /ID# 234519
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55413-2195
- MNGI Digestive Health, P. A. /ID# 238057
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New Jersey
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Marlton, New Jersey, Spojené státy, 08053
- Celen Medical Group Corp - Marlton /ID# 234922
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73106
- IPS Research Company /ID# 237672
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19104-4319
- Children's Hospital of Philadelphia - Main /ID# 234313
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Pittsburgh, Pennsylvania, Spojené státy, 15236
- Preferred Primary Care Physicians, Inc. /ID# 236436
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Texas
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Fort Worth, Texas, Spojené státy, 76104
- Cook Children's Med. Center /ID# 237537
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Houston, Texas, Spojené státy, 77030-2608
- Texas Children's Hospital /ID# 238304
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San Antonio, Texas, Spojené státy, 78215
- Sun Research Institute /ID# 236933
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West Virginia
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Morgantown, West Virginia, Spojené státy, 26506
- West Virginia University Hospitals /ID# 256841
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Valencia, Španělsko, 46017
- Hospital Universitario Dr. Peset /ID# 236755
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Eluxadoline 25mg
Eluxadoline 25mg, oral administration, twice daily |
Oral tablets
Ostatní jména:
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Experimentální: Eluxadoline 50mg
Eluxadoline 50mg, oral administration, twice daily |
Oral tablets
Ostatní jména:
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Experimentální: Eluxadoline 100mg
Eluxadoline 100mg, oral administration, twice daily |
Oral tablets
Ostatní jména:
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Experimentální: Placebo
Dose-matched placebo, oral administration, twice daily |
Oral tablets |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from baseline in stool consistency averaged over the 4-week Treatment Period
Časové okno: Baseline (2 Weeks prior to randomization) to Week 4
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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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from baseline in stool consistency for daily daytime and nighttime stool consistency scores
Časové okno: 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
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Change from baseline for daytime, nighttime, and 24-hour abdominal pain scores
Časové okno: Baseline (2 Weeks prior to randomization) to Week 4
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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
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Change from baseline for daytime, nighttime, and 24-hour bowel movement frequency
Časové okno: 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
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Change from baseline for daytime, nighttime, and 24 hour urgency-free days
Časové okno: Baseline (2 Weeks prior to randomization) to Week 4
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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
Časové okno: Baseline (2 Weeks prior to randomization) to Week 4
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Change from baseline in the number of fecal incontinence-free days in a week. |
Baseline (2 Weeks prior to randomization) to Week 4
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: ABBVIE INC., AbbVie
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 3030-202-002
- 2017 (Grant/smlouva NIH USA)
- 2017-003770-14 (Číslo EudraCT)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Časový rámec sdílení IPD
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Kritéria přístupu pro sdílení IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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