NCT02494687

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

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Eastern Regional Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Oncology Patients With Gastroparesis

Interventions

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

Timeline

• First posted: 2015-07-10
• Last updated: 2020-03-10

Locations

1 site across 1 country: United States