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Domperidone Expanded Access Protocol for Patients With Gastrointestinal Disorders

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ClinicalTrials.gov Identifier: NCT02567175
Expanded Access Status : Available
First Posted : October 2, 2015
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Kristin Fiorino, Children's Hospital of Philadelphia

Brief Summary:
FDA currently allows patients 12 years of age and older with various gastrointestinal (GI) conditions to be treated with Domperidone through the Expanded Access to Investigational Drugs program. These conditions include gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. Patients must have failed standard therapies to be eligible to receive Domperidone. This program facilitates availability of investigational drugs, (such as Domperidone) to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the patient's disease or condition.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Gastroparesis Chronic Constipation With Overflow Pseudo Obstruction Drug: Domperidone

Detailed Description:

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



Intervention Details:
  • Drug: Domperidone
    Other Name: Motilium

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Male or female
  2. Age 12 and older
  3. Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to 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.
  4. Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.
  5. Patient or Parent/Legal Guardian has signed informed consent and child assent (as appropriate) for the administration of Domperidone that informs the patient of potential adverse events including:

    • increased prolactin levels
    • extrapyramidal side effects
    • breast changes
    • cardiac arrhythmias including QT prolongation and death
    • There is a potential for increased risk of adverse events with the drugs listed in the Domperidone protocol addendum (see Appendix).
  6. Patients with a weight > 35kg
  7. Patients are able to swallow the Domperidone pill.

Exclusion Criteria:

  1. History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.
  2. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc> 450 milliseconds for males, QTc>470 milliseconds for females).
  3. Hepatic dysfunction
  4. Renal insufficiency
  5. Clinically significant electrolyte disorders.
  6. Gastrointestinal hemorrhage or obstruction
  7. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
  8. Pregnant or breast feeding female
  9. Known allergy to Domperidone
  10. The use of medications that interact with Domperidone. a. Subjects may be required to stop use (wash-out) of medications that interact with Domperidone. If the subject is not willing or able to stop use of the interacting medication, they may be excluded or withdrawn from the study at the investigator's discretion. Based on the medication the subject may be required to stop-use or wash out from, the PI will determine the appropriate washout period using clinical judgment. Some medications may require much longer washout periods than others, and this will be explained to each respective subject that requires stopping a medication.

Information from the National Library of Medicine

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


Contacts
Contact: Kristin Fiorino, MD 2674262866 fiorino@email.chop.edu
Contact: Nola Juste, MPH JUSTEL@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Contact: Kristin Fiorino, MD    267-426-2866    fiorino@email.chop.edu   
Principal Investigator: Kristin Fiorino, MD         
Sponsors and Collaborators
Kristin Fiorino

Responsible Party: Kristin Fiorino, Sponsor-Investigator, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02567175     History of Changes
Other Study ID Numbers: 14-010908
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
Gastroparesis
Constipation
Gastroesophageal Reflux
Digestive System Diseases
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Stomach Diseases
Paralysis
Neurologic Manifestations
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action