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

Last updated: March 9, 2020
Sponsor: Eastern Regional Medical Center
Overall Status: Planned

Phase

N/A

Condition

Neoplasms

Gastroparesis

Treatment

N/A

Clinical Study ID

NCT02494687
EP2014022
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 motilitydisorders such as nausea, vomiting, severe dyspepsia or severe chronic constipationrefractory 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 theirsymptoms.

  5. Patient has signed informed consent for the administration of domperidone that informsthe patient of potential adverse events including:

  • increased prolactin levels

  • extrapyramidal side-effects

  • breast changes

  • cardiac arrhythmias including QT prolongation and death

Exclusion

Exclusion Criteria: History of, or current, arrhythmias including ventricular tachycardia, ventricularfibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are notnecessarily excluded.

  1. Clinically significant bradycardia, sinus node dysfunction, or heart block. ProlongedQTc (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 Design

Study Start date:
Estimated Completion Date:

Study 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.

Connect with a study center

  • Eastern Regional Medical Center, Inc.

    Philadelphia, Pennsylvania 19124
    United States

    Planned

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