Domperidone in Refractory Gastroparesis

Phase 2

Terminated

• Conditions: Gastroparesis
• Interventions: Drug: Domperidone

• Registration Number: NCT00760461
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-26
• Study Start: 2008-10
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2016-09-15
• Status Verified: 2017-02
• Results First Submitted QC: 2017-08-17
• Last Update Submitted: 2017-08-17
• Results First Posted: 2017-08-18
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Domperidone	Domperidone	-

Primary Outcome Measures

Name	Time	Method
Gastroparesis Cardinal Symptom Index	upon study completion

Trial Locations

Locations (1)

Yale Digestive Diseases 40 Temple St, Suite 1A; 🇺🇸 New Haven, Connecticut, United States