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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

Tracking Information
First Submitted Date  ICMJE May 31, 2018
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 18, 2019
Actual Study Start Date  ICMJE June 1, 2014
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms
Official Title  ICMJE The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms
Brief Summary To prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroparesis
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Patients receiving Domperidone
Patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy.
Intervention: Drug: Domperidone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 16, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mayra Sanchez, MD 203-785-4138 mayra.sanchez@yale.edu
Contact: Roman Ryabtsev 203-785-4576 roman.ryabtsev@yale.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810287
Other Study ID Numbers  ICMJE 1410014717
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mayra Sanchez, MD Yale University
PRS Account Yale University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP