NCT03128398

Use of Domperidone for Treatment of Upper Gastrointestinal Disorders

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Palo Alto Medical Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an Expanded Access to Investigational Drug program available through the FDA. Some specific conditions to qualify for this program includes gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. Patients failing standard therapies for these conditions may be eligible to receive domperidone. This program facilitates availability of investigational drugs, (such as domperidone) to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor or treat the patients's disease or condition. Authorization must be obtained from FDA prior to the importation, interstate shipment and administration of domperidone.

Conditions

• Gastroparesis

Interventions

Type	Name	Description
DRUG	Domperidone	Availability of Domperidone to patients with serious gastrointestinal diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the patient's disease or condition.

Timeline

• First posted: 2017-04-25
• Last updated: 2022-10-27