NCT02494687

Brief Summary

Gastroparesis is a digestive disorder in which motility of the stomach is either slowed or absent. The gastroparesis prevents normal digestion from occurring. The purpose of this study is to provide oral Domperidone offered under the U.S. Food and Drug Administration (FDA) expanded access program, to patients that, based on the treating doctor's assessment, could benefit from , a prokinetic effect for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation.

Trial Health

55
Monitor

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

First QC Date

July 8, 2015

Last Update Submit

March 9, 2020

Conditions

Oncology Patients With Gastroparesis

Interventions

Oral DomperidoneDRUG

10 mg of oral domperidone administered (four times a day) for two weeks

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 refractory to standard therapy.
  • Patients must have a comprehensive evaluation (physical exam and also may include EGD, gastric emptying study, as clinically necessary) 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

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 (1)

Eastern Regional Medical Center, Inc.

Philadelphia, Pennsylvania, 19124, United States

AVAILABLE

MeSH Terms

Interventions

Domperidone

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Raman Battish, MD

CONTACT

215-537-7400Raman.Battish@ctca-hope.com

Jack Medendorp

CONTACT

215-537-3160Jack.Medendorp@ctca-hope.com

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 10, 2015

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

US(1)