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Use of Domperidone for Treatment of Upper Gastrointestinal Disorders

NCT03128398 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2022-10-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Palo Alto Medical Foundation

    lead OTHER

Principal Investigators

  • Katerina Shetler, MD · Palo Alto Medical Foundation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03128398 on ClinicalTrials.gov