Clinical Applications of Domperidone in Patients With Delayed Gastric Emptying

Digestive System Disease Clinical Trial

Official title:

Clinical Applications of Domperidone in Patients With Refractory Gastroesophageal Reflux Disease or Delayed Gastric Solid-Phase Emptying

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844622
• Other study ID #: 07-39-H-08
• Status: Completed
• Phase: N/A
• First received: April 29, 2013
• Last updated: May 15, 2017
• Start date: December 2007
• Est. completion date: February 19, 2015

Study information

• Verified date: May 2017
• Source: Mt. Sinai Medical Center, Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to treat patients with on-going slow stomach emptying(gastroesophageal reflux disease), who have failed to respond to standard therapy

Description:

This is a study on the effectiveness of domperidone, which increases movement through the digestive system for relief of symptoms, in patients who have delayed gastric solid-phase emptying

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 19, 2015
• Est. primary completion date: February 19, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Persistent esophagitis

• Heartburn

• Nausea

• Vomiting

• Severe dyspepsia

• Severe chronic constipation

Exclusion Criteria:

• History of, or current arrhythmias including ventricular tachycardia, - Ventricular fibrillation and Torsade des Pointes.

Related Conditions & MeSH terms

• Digestive System Disease
• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

Other:
• Domperidone
Domperidone dosage may be increased depending on how well the patient responds. However before increasing the dosage, patients will have follow-up EKG to evaluate any possible side effects including irregular heartbeats.

Locations

Country	Name	City	State
United States	Division of Gastroenterology, Mt. Sinai Medical Center	Miami Beach	Florida
United States	Mt. Sinai Medical Center, Division of Gastroenterology	Miami Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mt. Sinai Medical Center, Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Applications of Domperidone in Patients with Refractory Gastroesophageal Reflux Disease (GERD)or Delayed Gastric Solid-Phase Emptying	GERD or Delayed Gastric Emptying	5 years