Trials / No Longer Available
No Longer AvailableNCT04996134
Domperidone Expanded Access Treatment Program
Domperidone Protocol - FDA Expanded Access Program
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- —
Summary
To allow the use of domperidone by patients with gastrointestinal disorders who have failed standard therapy.
Detailed description
To provide oral domperidone to patients ≥12 years of age where, according to the investigator's judgment, a prokinetic effect is needed for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation in patients whom the potential benefit may outweigh the risk of cardiovascular adverse reactions including QT prolongation, Torsades de Pointes, and death.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Domperidone Oral Product | 10-30 mg of oral domperidone administered QID. |
Timeline
- First posted
- 2021-08-09
- Last updated
- 2026-01-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04996134. Inclusion in this directory is not an endorsement.