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Studio per esplorare l'effetto terapeutico di Eluxadoline nel trattamento della sindrome dell'intestino irritabile con diarrea nei bambini

17 settembre 2026 aggiornato da: AbbVie

Studio di fase 2, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, a dosaggio variabile per valutare la sicurezza e l'efficacia di Eluxadoline nei partecipanti pediatrici (età da 6 a 17 anni) con sindrome dell'intestino irritabile con diarrea (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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

272

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Bulgaria
      • Kozloduy, Bulgaria, 3320
        • MHATSv.Ivan Rilski /ID# 235399
      • Plovdiv, Bulgaria, 4001
        • University Hospital Plovdiv /ID# 235450
    • Gabrovo
      • Sevlievo, Gabrovo, Bulgaria, 5400
        • Medical center 1 Sevlievo /ID# 237473
  • Canada
      • Edmonton, Canada, T6G 1C9
        • Duplicate_Edmonton Clinic Health Academy (ECHA) /ID# 234917
      • Winnepeg, Canada, R3E 3P4
        • Manitoba Institute of Child Health /ID# 235448
  • Germania
      • Wuppertal, Germania, 42283
        • HELIOS Klinikum Wuppertal /ID# 237322
  • Olanda
    • North Holland
      • Amsterdam, North Holland, Olanda, 1105 AZ
        • Duplicate_Academisch Medisch Centrum /ID# 237117
  • Polonia
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polonia, 30-539
        • Specjalistyczne Gabinety Sp. z o.o. /ID# 236347
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polonia, 00-189
        • Centrum Zdrowia MDM /ID# 237269
      • Warsaw, Masovian Voivodeship, Polonia, 04-730
        • Duplicate_Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311
    • Podkarpackie Voivodeship
      • Rzeszów, Podkarpackie Voivodeship, Polonia, 35-302
        • Korczowski Bartosz Gabinet Lekarski /ID# 234683
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Polonia, 80-803
        • Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Polonia, 93-338
        • Instytut Centrum Zdrowia Matki Polki /ID# 237438
  • Regno Unito
      • Blackpool, Regno Unito, FY3 8NR
        • Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273
    • Greater London
      • London, Greater London, Regno Unito, SE5 9RS
        • Kings College Hospital NHS Foundation Trust /ID# 236305
    • Lancashire
      • Manchester, Lancashire, Regno Unito, M13 9WL
        • Duplicate_Manchester University NHS Foundation Trust /ID# 234663
  • Spagna
      • Valencia, Spagna, 46017
        • Hospital Universitario Dr. Peset /ID# 236755
  • Stati Uniti
    • Arkansas
      • Hot Springs, Arkansas, Stati Uniti, 71913
        • HealthStar Research of Hot Springs PLLC /ID# 234609
      • Little Rock, Arkansas, Stati Uniti, 72212-4187
        • Applied Research Center of Arkansas /ID# 238070
    • California
      • Corona, California, Stati Uniti, 92879
        • Kindred Medical Institute, LLC /ID# 237368
      • Garden Grove, California, Stati Uniti, 92845
        • Duplicate_VVCRD Research /ID# 234606
      • Paramount, California, Stati Uniti, 90723
        • Duplicate_Center for Clinical Trials LLC /ID# 234630
    • Florida
      • Miami, Florida, Stati Uniti, 33130
        • Sunrise Research Institute /ID# 237382
      • Miami, Florida, Stati Uniti, 33155
        • South Miami Medical & Research Group Inc. /ID# 234655
      • Miami, Florida, Stati Uniti, 33165
        • Valencia Medical & Research Center /ID# 234672
      • Miami, Florida, Stati Uniti, 33174
        • Florida Research Center, Inc. /ID# 236514
      • Miami Lakes, Florida, Stati Uniti, 33016
        • Duplicate_Wellness Clinical Research /ID# 237401
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30315
        • Global Research Associates /ID# 234646
      • Atlanta, Georgia, Stati Uniti, 30342
        • Children's Ctr Digestive, US /ID# 237575
      • Stockbridge, Georgia, Stati Uniti, 30281
        • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343
    • Illinois
      • Park Ridge, Illinois, Stati Uniti, 60068
        • Advocate Children's Hospital-Park Ridge /ID# 235388
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Indiana University Health Riley Hospital for Children /ID# 235400
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40517
        • Michael W. Simon, MD, PSC /ID# 236517
    • Maryland
      • New Market, Maryland, Stati Uniti, 21774-6154
        • Frederick County Pediatrics /ID# 234519
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55413-2195
        • MNGI Digestive Health, P. A. /ID# 238057
    • New Jersey
      • Marlton, New Jersey, Stati Uniti, 08053
        • Celen Medical Group Corp - Marlton /ID# 234922
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73106
        • IPS Research Company /ID# 237672
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104-4319
        • Children's Hospital of Philadelphia - Main /ID# 234313
      • Pittsburgh, Pennsylvania, Stati Uniti, 15236
        • Preferred Primary Care Physicians, Inc. /ID# 236436
    • Texas
      • Fort Worth, Texas, Stati Uniti, 76104
        • Cook Children's Med. Center /ID# 237537
      • Houston, Texas, Stati Uniti, 77030-2608
        • Texas Children's Hospital /ID# 238304
      • San Antonio, Texas, Stati Uniti, 78215
        • Sun Research Institute /ID# 236933
    • West Virginia
      • Morgantown, West Virginia, Stati Uniti, 26506
        • West Virginia University Hospitals /ID# 256841
  • Ungheria
      • Budapest, Ungheria, 1125
        • Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993
      • Sopron, Ungheria, 9400
        • Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341
      • Székesfehérvár, Ungheria, 8000
        • Vita Verum Medical Bt. /ID# 234321

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 6 anni a 17 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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:

    • Related to defecation

    • A change in frequency of stool

    • 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.

    • 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).

  • 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).

  • Participant has an average daytime abdominal pain score greater than or equal to 1.0 over the 2 weeks prior to randomization.

  • 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:

  • Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy).

  • 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.)

  • Participant has a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical GI obstruction or pseudo obstruction.

  • Participant has a history or current diagnosis of constipation with encopresis.

  • Participant meets the child/adolescent Rome IV criteria of IBS with constipation, IBS with constipation and diarrhea (mixed), unspecified IBS, or functional constipation.

  • 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.

  • Participant has a documented history of hepatic impairment as defined by Child-Pugh Classification Grade A, B or C.

  • 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.

  • Participant has celiac disease, or a positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy.

  • Participant has any congenital and/or acquired malabsorption syndrome (eg, Shwachman-Diamond syndrome).

  • Participant has a history of a microbiologically documented (ie, stool culture or medical history) GI infection within 3 months prior to Screening.

  • 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.

  • Participant has a history of diverticulitis within 3 months prior to Screening.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Eluxadoline 25mg

Eluxadoline 25mg, oral administration, twice daily
Droga: Eluxadoline

Oral tablets

Altri nomi:
  • Viberzi
Sperimentale: Eluxadoline 50mg

Eluxadoline 50mg, oral administration, twice daily
Droga: Eluxadoline

Oral tablets

Altri nomi:
  • Viberzi
Sperimentale: Eluxadoline 100mg

Eluxadoline 100mg, oral administration, twice daily
Droga: Eluxadoline

Oral tablets

Altri nomi:
  • Viberzi
Sperimentale: Placebo

Dose-matched placebo, oral administration, twice daily
Droga: Placebo

Oral tablets

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in stool consistency averaged over the 4-week Treatment Period
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline in stool consistency for daily daytime and nighttime stool consistency scores
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Change from baseline for daytime, nighttime, and 24 hour number of fecal incontinence-free days
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AbbVie

Investigatori

  • Direttore dello studio: ABBVIE INC., AbbVie

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 novembre 2017

Completamento primario (Effettivo)

17 agosto 2026

Completamento dello studio (Effettivo)

17 agosto 2026

Date di iscrizione allo studio

Primo inviato

8 novembre 2017

Primo inviato che soddisfa i criteri di controllo qualità

8 novembre 2017

Primo Inserito (Effettivo)

13 novembre 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 3030-202-002
  • 2017 (Sovvenzione/contratto NIH degli Stati Uniti)
  • 2017-003770-14 (Numero EudraCT)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Periodo di condivisione IPD

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Criteri di accesso alla condivisione IPD

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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