Domperidone for Gastroparesis in Solid Organ Transplantation

• Sponsor: David J. Lederer, M.D. (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00552422
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 42.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis.

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis; Gastroesophageal Reflux	Drug: domperidone	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Domperidone for Gastroparesis Associated With Solid Organ Transplantation
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Domperidone Arm 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.

Drug: domperidone; 10mg orally four times per day

Outcome Measures

Primary Outcome Measures

1. Symptomatic Improvement [2 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

• David J. Lederer, M.D.

Investigators

• Principal Investigator: David J Lederer, M.D., Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David J. Lederer, M.D., Herbert Irving Assistant Professor of Medicine and Epidemiology, Columbia University
• ClinicalTrials.gov Identifier: NCT00552422
• Other Study ID Numbers: AAAC3728
• First Posted: Nov 1, 2007
• Last Update Posted: Jul 10, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by David J. Lederer, M.D., Herbert Irving Assistant Professor of Medicine and Epidemiology, Columbia University: gastroparesis; gastroesophageal reflux
• Additional relevant MeSH terms: Gastroesophageal Reflux; Gastroparesis; Domperidone

Study Results

Participant Flow

Arm/Group Title	Domperidone Arm
Arm/Group 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. domperidone: 10mg orally four times per day
Period Title: Overall Study
STARTED	6
COMPLETED	6
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Domperidone Arm
Arm/Group 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. domperidone: 10mg orally four times per day
Overall Participants	6
Age, Customized (participants) [Number]
18-65	6 100%
Sex: Female, Male (Count of Participants)
Female	4 66.7%
Male	2 33.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Domperidone Arm
Arm/Group 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. domperidone: 10mg orally four times per day
Measure Participants	6
Number [participants]	6 100%

Adverse Events

Adverse Event Reporting Description	Adverse events were assessed systemically with routine ECG.
Arm/Group Title	Domperidone
Arm/Group Description	Participants ranged from 18-65 years of age. Gender composition was 60$% female and 40% male.
All Cause Mortality
	Domperidone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Domperidone
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	Domperidone
	Affected / at Risk (%)	# Events
Total	2/6 (33.3%)
Cardiac disorders
long QTc	2/6 (33.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.