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NCT01844622 Clinical Trial

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
Secondary ID
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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