Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 11:19 PM
Study NCT ID:
NCT04996134
Status:
AVAILABLE
Last Update Posted:
2025-02-11
First Post:
2021-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Domperidone Expanded Access Treatment Program
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Domperidone Protocol - FDA Expanded Access Program
Status:
AVAILABLE
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 17-123 (16-817) | OTHER | Aurora Baycare Medical Center | View |