Domperidone Expanded Access Protocol for Patients With Gastrointestinal Disorders
NCT02567175 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2024-08-01
Summary
FDA currently allows patients 12 years of age and older with various gastrointestinal (GI) conditions to be treated with Domperidone through the Expanded Access to Investigational Drugs program. These conditions include gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. Patients must have failed standard therapies to 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 patient's disease or condition.
Conditions
- Gastroesophageal Reflux
- Gastroparesis
- Chronic Constipation With Overflow
- Pseudo Obstruction
Interventions
- DRUG
-
Domperidone
Sponsors & Collaborators
-
Prasanna K Kapavarapu
lead OTHER
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- United States
Study Locations
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