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Domperidone for Gastroparesis in Solid Organ Transplantation

Primary Purpose

Gastroparesis, Gastroesophageal Reflux

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
domperidone
Sponsored by
David J. Lederer, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis focused on measuring gastroparesis, gastroesophageal reflux

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • gastroparesis or gastroesophageal reflux that is refractory to standard therapy.
  • signed informed consent

Exclusion Criteria:

  • serious cardiac arrhythmias
  • clinically significant bradycardia, sinus node dysfunction, or heart block.
  • prolonged QTc
  • clinically significant electrolyte disorders.
  • gastrointestinal hemorrhage or obstruction.
  • prolactinoma
  • pregnant or breast feeding female
  • known allergy to domperidone.

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Domperidone Arm

Arm Description

Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with significant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with significant renal impairment will be 20mg twice a day.

Outcomes

Primary Outcome Measures

Symptomatic Improvement
The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3.

Secondary Outcome Measures

Full Information

First Posted
October 31, 2007
Last Updated
June 17, 2015
Sponsor
David J. Lederer, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT00552422
Brief Title
Domperidone for Gastroparesis in Solid Organ Transplantation
Official Title
Domperidone for Gastroparesis Associated With Solid Organ Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Lack of perceived need for domperidone in this population
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David J. Lederer, M.D.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis.
Detailed Description
After heart or lung transplantation, the stomach tends to empty much slower than normal. This slow emptying is called "gastroparesis." Gastroparesis is uncomfortable and often leads to nausea and vomiting. In addition to drastically impacting quality of life, severe nausea and vomiting can also lead to malnutrition and an inability to take oral medications, contributing to complications of transplantation. Treatments for gastroparesis include both medical and surgical therapies that work for some but not all patients. Domperidone is a peripheral D2 antagonist that improves the emptying of the stomach in patients with gastroparesis. Domperidone is not FDA approved at this time. Some patients have developed lifethreatening abnormal heart rhythms after receiving domperidone intravenously. This problem has not been seen with domperidone given by mouth. We propose to administer domperidone by mouth at standard doses to solid organ transplant patients who have gastroparesis that is not responsive to standard medical therapies or who experience adverse drug side effects. This study will not be blinded (open-label) and has a single treatment arm (no control or placebo group).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis, Gastroesophageal Reflux
Keywords
gastroparesis, gastroesophageal reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Domperidone Arm
Arm Type
Experimental
Arm Description
Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with significant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with significant renal impairment will be 20mg twice a day.
Intervention Type
Drug
Intervention Name(s)
domperidone
Intervention Description
10mg orally four times per day
Primary Outcome Measure Information:
Title
Symptomatic Improvement
Description
The primary endpoint of the study is the achievement of a symptom grade of less then or equal to 3.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: gastroparesis or gastroesophageal reflux that is refractory to standard therapy. signed informed consent Exclusion Criteria: serious cardiac arrhythmias clinically significant bradycardia, sinus node dysfunction, or heart block. prolonged QTc clinically significant electrolyte disorders. gastrointestinal hemorrhage or obstruction. prolactinoma pregnant or breast feeding female known allergy to domperidone.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Lederer, M.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Domperidone for Gastroparesis in Solid Organ Transplantation

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