Domperidone in Refractory Gastroparesis

Yale University

Status and phase: Terminated; Phase 2

Conditions: Gastroparesis

Treatments: Drug: Domperidone

Study type: Interventional

Funder types: Other

Identifiers

NCT00760461

0809004202

Details and patient eligibility

About

The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female

• Age 18 and older

• Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.

• Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.

• Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

  • Increased prolactin levels
  • Breast changes
  • Extrapyramidal side effects
  • Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)

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. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.
• Gastrointestinal hemorrhage or obstruction.
• Presence of a prolactinoma (prolactin-releasing pituitary tumor).
• Pregnant or breast feedings female.
• Known allergy to domperidone

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Domperidone

Other group

Treatment:

Drug: Domperidone