NCT02227927

Brief Summary

Domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux disease (GERD), with upper GI symptoms, gastroparesis, and chronic constipation. This is a long-term treatment program for prescription of this drug to all patients who, in the investigators' judgement, could benefit from its use.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

2 active sites

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 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

First QC Date

August 25, 2014

Last Update Submit

June 25, 2025

Conditions

Gastroesophageal Reflux DiseaseGERDGastroparesis

Keywords

Gastroesophageal Reflux DiseaseGERDGastroparesisDomperidone

Interventions

DomperidoneDRUG

10-30mg oral dose, four times daily.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • Age 18 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 including:
  • increased prolactin levels
  • extrapyramidal side effects
  • breast changes
  • cardiac arrhythmias including QT prolongation and death
  • There is a potential for increased risk of adverse events with the drugs listed in the domperidone protocol addendum.

You may not qualify if:

  • History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des 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).
  • 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 (2)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Gastroesophageal RefluxGastroparesis

Interventions

Domperidone

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2014

First Posted

August 28, 2014

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations

US(2)