Domperidone Expanded Access Program for Oncology Patients With Gastroparesis Who Have Failed Standard Therapy

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.

Study Overview

• Status: Available
• Conditions: Oncology Patients With Gastroparesis
• Intervention / Treatment: Drug: Oral Domperidone; Drug: Oral Domperidone; Drug: Oral Domperidone

Detailed Description

At the discretion of the Investigator, 10-30 mg of oral domperidone is administered QID (four times a day). The Investigator will be starting patients on 10 mg four times a day for 2 weeks, then increase to 20 mg four times a day for 2 weeks. The participant will be evaluated at each time point. If the participant still is not having relief of symptoms the investigator may increase their dose to 30mg four times a day.

• Study Type: Expanded Access

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19124
      • Available
      • Eastern Regional Medical Center, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female
2. Age 18 and older
3. 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.
4. 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.

5. 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

Exclusion Criteria:

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.

1. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc> 450 milliseconds for males, QTc>470 milliseconds for females).
2. Clinically significant electrolyte disorders.
3. Gastrointestinal hemorrhage or obstruction
4. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
5. Pregnant or breast feeding female
6. Known allergy to domperidone

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Eastern Regional Medical Center

Study record dates

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (ESTIMATE): July 10, 2015

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Neoplasms; Gastroparesis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine Antagonists; Domperidone
• Other Study ID Numbers: EP2014022