Studie zur Erforschung der therapeutischen Wirkung von Eluxadolin bei der Behandlung des Reizdarmsyndroms mit Durchfall bei Kindern
Phase 2, randomisierte, doppelblinde, placebokontrollierte Parallelgruppen-Dosisfindungsstudie zur Bewertung der Sicherheit und Wirksamkeit von Eluxadolin bei pädiatrischen Teilnehmern (Alter 6 bis 17 Jahre) mit Reizdarmsyndrom mit Durchfall (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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Kozloduy, Bulgarien, 3320
- MHATSv.Ivan Rilski /ID# 235399
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Plovdiv, Bulgarien, 4001
- University Hospital Plovdiv /ID# 235450
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Gabrovo
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Sevlievo, Gabrovo, Bulgarien, 5400
- Medical center 1 Sevlievo /ID# 237473
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Wuppertal, Deutschland, 42283
- HELIOS Klinikum Wuppertal /ID# 237322
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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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North Holland
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Amsterdam, North Holland, Niederlande, 1105 AZ
- Duplicate_Academisch Medisch Centrum /ID# 237117
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polen, 30-539
- Specjalistyczne Gabinety Sp. z o.o. /ID# 236347
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 00-189
- Centrum Zdrowia MDM /ID# 237269
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Warsaw, Masovian Voivodeship, Polen, 04-730
- Duplicate_Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311
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Podkarpackie Voivodeship
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Rzeszów, Podkarpackie Voivodeship, Polen, 35-302
- Korczowski Bartosz Gabinet Lekarski /ID# 234683
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polen, 80-803
- Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, Polen, 93-338
- Instytut Centrum Zdrowia Matki Polki /ID# 237438
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Valencia, Spanien, 46017
- Hospital Universitario Dr. Peset /ID# 236755
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Budapest, Ungarn, 1125
- Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993
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Sopron, Ungarn, 9400
- Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341
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Székesfehérvár, Ungarn, 8000
- Vita Verum Medical Bt. /ID# 234321
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Arkansas
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Hot Springs, Arkansas, Vereinigte Staaten, 71913
- HealthStar Research of Hot Springs PLLC /ID# 234609
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Little Rock, Arkansas, Vereinigte Staaten, 72212-4187
- Applied Research Center of Arkansas /ID# 238070
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California
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Corona, California, Vereinigte Staaten, 92879
- Kindred Medical Institute, LLC /ID# 237368
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Garden Grove, California, Vereinigte Staaten, 92845
- Duplicate_VVCRD Research /ID# 234606
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Paramount, California, Vereinigte Staaten, 90723
- Duplicate_Center for Clinical Trials LLC /ID# 234630
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Florida
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Miami, Florida, Vereinigte Staaten, 33130
- Sunrise Research Institute /ID# 237382
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Miami, Florida, Vereinigte Staaten, 33155
- South Miami Medical & Research Group Inc. /ID# 234655
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Miami, Florida, Vereinigte Staaten, 33165
- Valencia Medical & Research Center /ID# 234672
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Miami, Florida, Vereinigte Staaten, 33174
- Florida Research Center, Inc. /ID# 236514
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Miami Lakes, Florida, Vereinigte Staaten, 33016
- Duplicate_Wellness Clinical Research /ID# 237401
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30315
- Global Research Associates /ID# 234646
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Atlanta, Georgia, Vereinigte Staaten, 30342
- Children's Ctr Digestive, US /ID# 237575
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Stockbridge, Georgia, Vereinigte Staaten, 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, Vereinigte Staaten, 60068
- Advocate Children's Hospital-Park Ridge /ID# 235388
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Indiana
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Indianapolis, Indiana, Vereinigte Staaten, 46202
- Indiana University Health Riley Hospital for Children /ID# 235400
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Kentucky
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Lexington, Kentucky, Vereinigte Staaten, 40517
- Michael W. Simon, MD, PSC /ID# 236517
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Maryland
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New Market, Maryland, Vereinigte Staaten, 21774-6154
- Frederick County Pediatrics /ID# 234519
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55413-2195
- MNGI Digestive Health, P. A. /ID# 238057
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New Jersey
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Marlton, New Jersey, Vereinigte Staaten, 08053
- Celen Medical Group Corp - Marlton /ID# 234922
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Oklahoma
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Oklahoma City, Oklahoma, Vereinigte Staaten, 73106
- IPS Research Company /ID# 237672
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104-4319
- Children's Hospital of Philadelphia - Main /ID# 234313
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15236
- Preferred Primary Care Physicians, Inc. /ID# 236436
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Texas
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Fort Worth, Texas, Vereinigte Staaten, 76104
- Cook Children's Med. Center /ID# 237537
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Houston, Texas, Vereinigte Staaten, 77030-2608
- Texas Children's Hospital /ID# 238304
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San Antonio, Texas, Vereinigte Staaten, 78215
- Sun Research Institute /ID# 236933
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West Virginia
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Morgantown, West Virginia, Vereinigte Staaten, 26506
- West Virginia University Hospitals /ID# 256841
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Blackpool, Vereinigtes Königreich, FY3 8NR
- Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273
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Greater London
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London, Greater London, Vereinigtes Königreich, SE5 9RS
- Kings College Hospital NHS Foundation Trust /ID# 236305
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Lancashire
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Manchester, Lancashire, Vereinigtes Königreich, M13 9WL
- Duplicate_Manchester University NHS Foundation Trust /ID# 234663
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Eluxadoline 25mg
Eluxadoline 25mg, oral administration, twice daily |
Oral tablets
Andere Namen:
|
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Experimental: Eluxadoline 50mg
Eluxadoline 50mg, oral administration, twice daily |
Oral tablets
Andere Namen:
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Experimental: Eluxadoline 100mg
Eluxadoline 100mg, oral administration, twice daily |
Oral tablets
Andere Namen:
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Experimental: Placebo
Dose-matched placebo, oral administration, twice daily |
Oral tablets |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from baseline in stool consistency averaged over the 4-week Treatment Period
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change from baseline in stool consistency for daily daytime and nighttime stool consistency scores
Zeitfenster: 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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Change from baseline for daytime, nighttime, and 24-hour abdominal pain scores
Zeitfenster: 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
Zeitfenster: Baseline (2 Weeks prior to randomization) to Week 4
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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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: ABBVIE INC., AbbVie
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 3030-202-002
- 2017 (US NIH Stipendium/Vertrag)
- 2017-003770-14 (EudraCT-Nummer)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD-Sharing-Zugriffskriterien
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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