Back to resultsClinical Applications of Domperidone in Patients With Delayed Gastric Emptying
Primary Purpose
Digestive System Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Domperidone
Sponsored by
About this trial
This is an interventional supportive care trial for Digestive System Disease focused on measuring Digestive System Diseases Disease
Eligibility Criteria
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.
Sites / Locations
- Division of Gastroenterology, Mt. Sinai Medical Center
- Mt. Sinai Medical Center, Division of Gastroenterology
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Domperidone
Arm Description
Domperidone will be given at 10 mg before each meal and at bedtime. At completion of the study, patients will receive standard medical therapy
Outcomes
Primary Outcome Measures
Clinical Applications of Domperidone in Patients with Refractory Gastroesophageal Reflux Disease (GERD)or Delayed Gastric Solid-Phase Emptying
GERD or Delayed Gastric Emptying
Secondary Outcome Measures
Full Information
NCT ID
NCT01844622
First Posted
April 29, 2013
Last Updated
May 15, 2017
Sponsor
Mt. Sinai Medical Center, Miami
1. Study Identification
Unique Protocol Identification Number
NCT01844622
Brief Title
Clinical Applications of Domperidone in Patients With Delayed Gastric Emptying
Official Title
Clinical Applications of Domperidone in Patients With Refractory Gastroesophageal Reflux Disease or Delayed Gastric Solid-Phase Emptying
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 19, 2015 (Actual)
Study Completion Date
February 19, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mt. Sinai Medical Center, Miami
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive System Disease
Keywords
Digestive System Diseases Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Domperidone
Arm Type
Other
Arm Description
Domperidone will be given at 10 mg before each meal and at bedtime. At completion of the study, patients will receive standard medical therapy
Intervention Type
Other
Intervention Name(s)
Domperidone
Other Intervention Name(s)
Motilium, Motillium
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Applications of Domperidone in Patients with Refractory Gastroesophageal Reflux Disease (GERD)or Delayed Gastric Solid-Phase Emptying
Description
GERD or Delayed Gastric Emptying
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie S. Barkin, M.D.
Organizational Affiliation
Mt. Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Gastroenterology, Mt. Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Mt. Sinai Medical Center, Division of Gastroenterology
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Applications of Domperidone in Patients With Delayed Gastric Emptying
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