Back to resultsDomperidone Expanded Access Program for Oncology Patients With Gastroparesis Who Have Failed Standard Therapy
Primary Purpose
Oncology Patients With Gastroparesis
Status
Available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Oral Domperidone
Oral Domperidone
Oral Domperidone
Sponsored by
About this trial
This is an expanded access trial for Oncology Patients With Gastroparesis
Eligibility Criteria
Inclusion Criteria:
- Male or female
- Age 18 and older
- 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 refractory to standard therapy.
- Patients must have a comprehensive evaluation (physical exam and also may include EGD, gastric emptying study, as clinically necessary) to eliminate other causes of their symptoms.
Patient has signed informed consent 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
Exclusion Criteria:
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.
- Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc> 450 milliseconds for males, QTc>470 milliseconds for females).
- Clinically significant electrolyte disorders.
- Gastrointestinal hemorrhage or obstruction
- Presence of a prolactinoma (prolactin-releasing pituitary tumor).
- Pregnant or breast feeding female
- Known allergy to domperidone
Sites / Locations
- Eastern Regional Medical Center, Inc.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02494687
First Posted
July 8, 2015
Last Updated
March 9, 2020
Sponsor
Eastern Regional Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02494687
Brief Title
Domperidone Expanded Access Program for Oncology Patients With Gastroparesis Who Have Failed Standard Therapy
Official Title
Domperidone Expanded Access Program for Oncology Patients With Gastroparesis Who Have Failed Standard Therapy
Study Type
Expanded Access
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Regional Medical Center
4. Oversight
5. Study Description
Brief Summary
Gastroparesis is a digestive disorder in which motility of the stomach is either slowed or absent. The gastroparesis prevents normal digestion from occurring. The purpose of this study is to provide oral Domperidone offered under the U.S. Food and Drug Administration (FDA) expanded access program, to patients that, based on the treating doctor's assessment, could benefit from , a prokinetic effect for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation.
Detailed Description
At the discretion of the Investigator, 10-30 mg of oral domperidone is administered QID (four times a day). The Investigator will be starting patients on 10 mg four times a day for 2 weeks, then increase to 20 mg four times a day for 2 weeks. The participant will be evaluated at each time point. If the participant still is not having relief of symptoms the investigator may increase their dose to 30mg four times a day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology Patients With Gastroparesis
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oral Domperidone
Intervention Description
10 mg of oral domperidone administered (four times a day) for two weeks
Intervention Type
Drug
Intervention Name(s)
Oral Domperidone
Intervention Description
Increased to 20 mg four times a day for 2 weeks at the Investigator's discretion
Intervention Type
Drug
Intervention Name(s)
Oral Domperidone
Intervention Description
Increased to 30 mg four times a day at the Investigator's discretion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Male or female
Age 18 and older
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 refractory to standard therapy.
Patients must have a comprehensive evaluation (physical exam and also may include EGD, gastric emptying study, as clinically necessary) to eliminate other causes of their symptoms.
Patient has signed informed consent 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
Exclusion Criteria:
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.
Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc> 450 milliseconds for males, QTc>470 milliseconds for females).
Clinically significant electrolyte disorders.
Gastrointestinal hemorrhage or obstruction
Presence of a prolactinoma (prolactin-releasing pituitary tumor).
Pregnant or breast feeding female
Known allergy to domperidone
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raman Battish, MD
Phone
215-537-7400
Email
Raman.Battish@ctca-hope.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jack Medendorp
Phone
215-537-3160
Email
Jack.Medendorp@ctca-hope.com
Facility Information:
Facility Name
Eastern Regional Medical Center, Inc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raman Battish, MD
Phone
215-537-7400
Email
Raman.Battish@ctca-hope.com
First Name & Middle Initial & Last Name & Degree
Jack Medendorp
Phone
215-537-3160
Email
Jack.Medendorp@ctca-hope.com
12. IPD Sharing Statement
Learn more about this trial
Domperidone Expanded Access Program for Oncology Patients With Gastroparesis Who Have Failed Standard Therapy
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