deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT02699385

A Study to Evaluate the Safety and Efficacy of Domperidone in Pediatric Participants With Nausea and Vomiting Due to Acute Gastroenteritis

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Prospective Study to Evaluate the Safety and Efficacy of Domperidone in 6-month-old to 12-year-old Pediatric Subjects With Nausea and Vomiting Due to Acute Gastroenteritis

Sponsor: Janssen-Cilag International NV

Conditions Gastroenteritis
Interventions Domperidone Oral Rehydration Therapy Placebo
Updated 12 times since 2017 Last updated: Mar 18, 2019 Started: Dec 7, 2015 Primary completion: Aug 3, 2017 Completion: Aug 3, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Study prematurely terminated upon recommendation of IDMC due to lack of efficacy.

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This PHASE3 trial investigates Gastroenteritis and is currently terminated or withdrawn. Janssen-Cilag International NV leads this study, which shows 12 recorded versions since 2015 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Apr 2017 · 3 months · monthly snapshotRecruiting~Apr 2017 – ~May 2017 · 30 days · monthly snapshotRecruiting~May 2017 – ~Jul 2017 · 2 months · monthly snapshotRecruiting~Jul 2017 – ~Oct 2017 · 3 months · monthly snapshotRecruiting~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshotTerminated~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshotTerminated~Nov 2018 – ~Apr 2019 · 5 months · monthly snapshotTerminated~Apr 2019 – ~Jan 2021 · 21 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 12 months · monthly snapshotTerminated

Change History

12 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE3

  5. Apr 2019 — Jan 2021 [monthly]

    Terminated PHASE3

▶ Show 7 earlier versions

  1. Nov 2018 — Apr 2019 [monthly]

    Terminated PHASE3

  2. Jun 2018 — Nov 2018 [monthly]

    Terminated PHASE3

  3. Oct 2017 — Jun 2018 [monthly]

    Terminated PHASE3

    Status: Recruiting → Terminated

  4. Jul 2017 — Oct 2017 [monthly]

    Recruiting PHASE3

  5. May 2017 — Jul 2017 [monthly]

    Recruiting PHASE3

  6. Apr 2017 — May 2017 [monthly]

    Recruiting PHASE3

  7. Jan 2017 — Apr 2017 [monthly]

    Recruiting PHASE3

    First recorded

Dec 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Janssen-Cilag International NV
Data source: Janssen-Cilag International NV

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Barnsley, United Kingdom , Brussels, Belgium , Burriana, Spain , Cape Town, South Africa , Durban, South Africa , Gandia, Spain , Gröbming, Austria , Herbeumont, Belgium , Ipswich, United Kingdom , Krugersdorp, South Africa and 19 more locations