Domperidone for Gastroparesis in Solid Organ Transplantation

NCT00552422 | Terminated Results

• 1 other identifier: AAAC3728
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastroparesis; Gastroesophageal Reflux

Keywords

gastroparesis; gastroesophageal reflux

Outcome Measures

Primary Outcomes (1)

• Symptomatic Improvement

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

  2 months

Study Arms (1)

Domperidone Arm

EXPERIMENTAL

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

Interventions

domperidone DRUG

10mg orally four times per day

Domperidone Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• David J. Lederer, M.D.: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Gastroparesis; Gastroesophageal Reflux

Interventions

Domperidone

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: David Lederer
• Organization: Columbia University

tjb2134@cumc.columbia.edu

212-342-4167

Study Officials

• David J Lederer, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Herbert Irving Assistant Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: October 31, 2007
• First Posted: November 1, 2007
• Study Start: March 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 10, 2015
• Results First Posted: July 10, 2015

Record last verified: 2015-06

Locations

US (1)