Domperidone for Refractory Gastrointestinal Disorders
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Investigational New Drug Program for the Use of Domperidone in the Treatment of Refractory Gastroesophageal Reflux Disease and Other Gastrointestinal Motility Disorders|
- Improvement of symptoms for patients with gastrointestinal disorders who have failed or suffered adverse effects from standard medical treatment. [ Time Frame: Domperidone will be prescrided as long as patients benefit from taking it. ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
All eligible subjects will receive domperidone in an open label, single group assignment.
10 mg of oral domperidone will be administered 4 times daily. This dose may be increased to 20 mg 4 times daily or 30 mg 4 times daily, depending on how the subject responds to the drug.
Other Name: Domperidone maleate, Motilium
Domperidone is a dopamine-2 receptor antagonist. It acts as a prokinetic agent through its effects on the chemoreceptor trigger zone and the motor function of the stomach and small intestines. It does not cause any adverse neurological symptoms and has an excellent safety profile for long-term oral administration in recommended doses.
In the United States, domperidone is not approved by the Food and Drug Administration (FDA) and cannot be obtained by routine prescriptions or covered by health care insurance plans. It is also illegal to write a prescription for the subject to obtain the drug outside the U.S. Domperidone can be administered legally by obtaining a FDA Investigational New Drug (IND) application with Institutional Review Board (IRB) approval.
This study will follow FDA and IRB regulations and provide domperidone to subjects with gastrointestinal disorders who have failed from standard therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00777439
|Contact: Mary R. Beaves, BSNfirstname.lastname@example.org|
|Contact: George L. Arnold, MDemail@example.com|
|United States, Pennsylvania|
|Associates in Gastroenterology||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Mary R. Beaves, BSN 412-623-1309 firstname.lastname@example.org|
|Principal Investigator: George L. Arnold, MD|
|Principal Investigator:||George L. Arnold, MD||George L. Arnold, MD, FACP|