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The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms

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ClinicalTrials.gov Identifier: NCT03810287
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
To prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy.

Condition or disease Intervention/treatment Phase
Gastroparesis Drug: Domperidone Early Phase 1

Detailed Description:
The primary objective of this study is to prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms
Actual Study Start Date : June 1, 2014
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Domperidone

Arm Intervention/treatment
Experimental: Patients receiving Domperidone
Patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy.
Drug: Domperidone
Domperidone will be prescribed for patients with upper GI symptoms at an initial dose of 10 mg up to 4 times a day (prior to each meal and at bedtime). It is possible that the dose of domperidone may be increased to 20 mg if symptoms are not adequately controlled on the initial dose.




Primary Outcome Measures :
  1. Reduction of upper GI symptoms [ Time Frame: 10 years ]
    Domperidone will be prescribed at an initial dose of 10 mg up to 4 times a day (prior to each meal and at bedtime). It is possible that the dose of domperidone may be increased to 20 mg if symptoms are not adequately controlled on the initial dose. This will be determined by the physician at follow up visits. Maximum dose that will be prescribed is 30 mg four times daily. The study will continue until the medication is FDA approved. The study will look for a 50% reduction of symptoms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females who are 18 years of age or older
  2. Symptoms or manifestations secondary to Gastro esophageal reflux disease (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.

Exclusion Criteria:

  1. i. 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.

    ii. Clinically significant bradycardia, sinus node dysfunction, or heart block.

    iii. Prolonged QTc (QTc>450 milliseconds for males, QTc>470 milliseconds for females)

    iv. Clinically significant electrolyte disorders.

  2. Gastrointestinal hemorrhage or obstruction.
  3. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
  4. Pregnant or breast feedings female.
  5. Known allergy to domperidone

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): NCT03810287


Contacts
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Contact: Mayra Sanchez, MD 203-785-4138 mayra.sanchez@yale.edu
Contact: Roman Ryabtsev 203-785-4576 roman.ryabtsev@yale.edu

Locations
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United States, Connecticut
Yale Digestive Diseases Recruiting
New Haven, Connecticut, United States, 06510
Contact: Roman Ryabtsev, MD    203-785-4576    roman.ryabtsev@yale.edu   
Principal Investigator: Mayra Sanchez, MD         
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Mayra Sanchez, MD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03810287     History of Changes
Other Study ID Numbers: 1410014717
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
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