Trials / Recruiting
RecruitingNCT01696734
Domperidone in Treating Patients With Gastrointestinal Disorders
Treatment Protocol for the Compassionate Use of Domperidone
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Digestive System Disorder
- Dyspepsia
- Esophagitis
- Gastroesophageal Reflux Disease
- Gastroparesis
- Heartburn
- Nausea and Vomiting
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Domperidone | Given PO |
| OTHER | Questionnaire Administration | Ancillary studies |
Timeline
- Start date
- 2012-10-23
- Primary completion
- 2027-10-31
- Completion
- 2027-10-31
- First posted
- 2012-10-01
- Last updated
- 2026-04-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01696734. Inclusion in this directory is not an endorsement.