NCT04996134

Brief Summary

To allow the use of domperidone by patients with gastrointestinal disorders who have failed standard therapy.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

First QC Date

August 3, 2021

Last Update Submit

January 16, 2026

Conditions

Gastroparesis

Interventions

Domperidone Oral ProductDRUG

10-30 mg of oral domperidone administered QID.

Eligibility Criteria

Age12 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • Age 12 and older
  • Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.
  • Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.
  • Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events

You may not qualify if:

  • History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsades de Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.
  • Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc \> 450 milliseconds for males, QTc\>470 milliseconds for females).
  • Hepatic dysfunction
  • Renal insufficiency
  • Clinically significant electrolyte disorders.
  • Gastrointestinal hemorrhage or obstruction
  • Presence of a prolactinoma (prolactin-releasing pituitary tumor).
  • Pregnant or breast feeding female
  • Known allergy to domperidone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John Bosco, MD

    Aurora BayCare Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 9, 2021

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

US(1)