Domperidone Expanded Access Protocol for Patients With 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: NCT02567175|
Expanded Access Status : Available
First Posted : October 2, 2015
Last Update Posted : November 29, 2018
|Condition or disease||Intervention/treatment|
|Gastroesophageal Reflux Gastroparesis Chronic Constipation With Overflow Pseudo Obstruction||Drug: Domperidone|
Expanded Access Program Design:
The purpose of the Expanded Access Program is to provide oral Domperidone to patients' ≥12 years of age where, according to the investigator's judgment, a prokinetic effect is needed for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation.
The objective of the Expanded Access Program is to allow the use of Domperidone by patients with gastrointestinal disorders who have failed standard therapy. Failed standard therapy can be constituted by the following treatments: PPI Therapy, Erythromycin, allergy to medications. Subject must be on these therapies for a time period of 1 month before they are considered to be ineffective.
|Study Type :||Expanded Access|
|Official Title:||Domperidone Expanded Access Protocol for Patients With Gastrointestinal Disorders|
- Drug: Domperidone
Other Name: Motilium
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): NCT02567175
|Contact: Kristin Fiorino, MDemail@example.com|
|Contact: Nola Juste, MPH||JUSTEL@email.chop.edu|
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Kristin Fiorino, MD 267-426-2866 firstname.lastname@example.org|
|Principal Investigator: Kristin Fiorino, MD|