Domperidone for Refractory Gastrointestinal Disorders
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00777439|
Recruitment Status : Recruiting
First Posted : October 22, 2008
Last Update Posted : August 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gastroparesis||Drug: Domperidone||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2018|
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
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777439
|Contact: Kelly A Kolesar, BSNfirstname.lastname@example.org|
|Contact: George L. Arnold, MDemail@example.com|
|United States, Pennsylvania|
|Division of Gastroenterology, Hepatology and Nutrition, UPMC Presbyterian Digesive Disorders Center, 3rd Floor, 200 Lothrop Street||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Kelly A. Kolesar, BSN 412-864-7087 firstname.lastname@example.org|
|Principal Investigator: George L. Arnold, MD|
|Principal Investigator:||George L. Arnold, MD||George L. Arnold, MD, FACP|