Domperidone Expanded Access Program for Oncology Patients With Gastroparesis Who Have Failed Standard Therapy

Oncology Patients With Gastroparesis Clinical Trial

Official title:

Domperidone Expanded Access Program for Oncology Patients With Gastroparesis Who Have Failed Standard Therapy

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT02494687
• Other study ID #: EP2014022
• Status: Available

Study information

• Verified date: March 2020
• Source: Eastern Regional Medical Center
• Contact: Raman Battish, MD
• Phone: 215-537-7400
• Email: Raman.Battish[@]ctca-hope.com
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female

2. Age 18 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 refractory to standard therapy.

4. 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.

5. 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.

1. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc> 450 milliseconds for males, QTc>470 milliseconds for females).

2. Clinically significant electrolyte disorders.

3. Gastrointestinal hemorrhage or obstruction

4. Presence of a prolactinoma (prolactin-releasing pituitary tumor).

5. Pregnant or breast feeding female

6. Known allergy to domperidone

Related Conditions & MeSH terms

• Gastroparesis
• Neoplasms
• Oncology Patients With Gastroparesis

Intervention

Drug:
• Oral Domperidone
10 mg of oral domperidone administered (four times a day) for two weeks
• Oral Domperidone
Increased to 20 mg four times a day for 2 weeks at the Investigator's discretion
• Oral Domperidone
Increased to 30 mg four times a day at the Investigator's discretion

Locations

Country	Name	City	State
United States	Eastern Regional Medical Center, Inc.	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Regional Medical Center

Country where clinical trial is conducted

United States,