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| Sponsor: | Columbia University |
|---|---|
| Information provided by: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT00552422 |
Purpose
The purpose of this study is to examine the clinical response to domperidone in solid organ transplant recipients with gastroparesis.
| Condition | Intervention |
|---|---|
|
Gastroparesis Gastroesophageal Reflux |
Drug: domperidone |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Domperidone for Gastroparesis Associated With Solid Organ Transplantation |
| Estimated Enrollment: | 25 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Domperidone
|
Drug: domperidone
10mg orally four times per day
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: David J Lederer, M.D. | (212) 305-7771 |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact 212-305-7771 | |
| Principal Investigator: David J Lederer, M.D., M.S. | |
| Sub-Investigator: Thresiamma Lukose, Pharm.D. | |
| Sub-Investigator: Selim M Arcasoy, M.D. | |
| Sub-Investigator: Jessie Wilt, M.D. | |
| Sub-Investigator: Steven M Kawut, M.D., M.S. | |
| Principal Investigator: | David J Lederer, M.D. | Columbia University |
More Information
| Responsible Party: | Columbia University ( David Lederer ) |
| Study ID Numbers: | AAAC3728 |
| Study First Received: | October 31, 2007 |
| Last Updated: | February 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00552422 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
gastroparesis gastroesophageal reflux |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Physiological Effects of Drugs Gastrointestinal Agents Antiemetics Dopamine Antagonists Gastroesophageal Reflux Pharmacologic Actions Esophageal Motility Disorders Deglutition Disorders Paralysis |
Signs and Symptoms Digestive System Diseases Stomach Diseases Domperidone Autonomic Agents Therapeutic Uses Neurologic Manifestations Dopamine Agents Peripheral Nervous System Agents Esophageal Diseases Central Nervous System Agents Gastroparesis |
