Treatment Protocol for the Compassionate Use of Domperidone
M.D. Anderson Cancer Center
Summary
This phase III trial studies how well domperidone works in treating patients with gastrointestinal disorders. Domperidone may help control chronic gastrointestinal disorders and their symptoms, such as pain, bloating, and nausea and vomiting, by stimulating contraction of the stomach to increase its ability to empty itself of food.
Description
PRIMARY OBJECTIVES: I. To provide treatment with domperidone to patients \>= 16 years of age where, according to the investigators' judgment, a prokinetic effect is needed for the relief of gastrointestinal (GI) motility disorders. OUTLINE: Patients receive domperidone orally (PO) thrice daily (TID) or four times daily (QID). Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for at least 30 days.
Eligibility
- Age range
- 16+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with GI disorders who have failed standard therapy * Symptoms or manifestations of: a) gastroparesis; b) refractory gastroesophageal reflux disease (GERD) including persistent esophagitis, refractory heartburn, reflux-related laryngitis, and respiratory symptoms; or c) severe dyspepsia * Completion of a comprehensive evaluation, including clinical history and physical examination, to eliminate other causes of their symptoms * Patient has signed the informed consent document agreeing to the use of the study drug, domperidone * White blood cell (WBC) with differen…
Interventions
- DrugDomperidone
Given PO
- OtherQuestionnaire Administration
Ancillary studies
Location
- M D Anderson Cancer CenterHouston, Texas