Treatment Use of Domperidone for Gastroparesis

Scott Gabbard, MD

Status

Conditions: Gastroparesis; Gastroesophageal Reflux Disease; GERD

Treatments: Drug: Domperidone

Study type: Expanded Access

Funder types: Other

Identifiers

NCT02227927

CCF-Domperidone (Other Identifier)

Details and patient eligibility

About

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.

Full description

The Treatment Use of Domperidone program is also available at the Cleveland Clinic Florida/Weston Gastroenterology Department. This is not a "traditional" research study, but an expanded use protocol for patients who may benefit from the drug. Because of this, this study is enrolling patients via invitation only, and as such, all expenses associated with the drug, initiation and follow up of treatment are the responsibility of the patient or the patient's third party payer.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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.
• 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