Domperidone in Refractory Gastroparesis

Gastroparesis Clinical Trial

Official title:

Domperidone in Refractory Gastroparesis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00760461
• Other study ID #: 0809004202
• Status: Terminated
• Phase: Phase 2
• First received: September 24, 2008
• Last updated: August 17, 2017
• Start date: October 2008
• Est. completion date: July 2011

Study information

• Verified date: February 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Drug:
• Domperidone
10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily

Locations

Country	Name	City	State
United States	Yale Digestive Diseases 40 Temple St, Suite 1A	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastroparesis Cardinal Symptom Index		upon study completion