Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Gastroparesis is a digestive disorder in which motility of the stomach is either slowed or absent. The gastroparesis prevents normal digestion from occurring. The purpose of this study is to provide oral Domperidone offered under the U.S. Food and Drug Administration (FDA) expanded access program, to patients that, based on the treating doctor's assessment, could benefit from , a prokinetic effect for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation.
At the discretion of the Investigator, 10-30 mg of oral domperidone is administered QID (four times a day). The Investigator will be starting patients on 10 mg four times a day for 2 weeks, then increase to 20 mg four times a day for 2 weeks. The participant will be evaluated at each time point. If the participant still is not having relief of symptoms the investigator may increase their dose to 30mg four times a day.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Domperidone | Drug | 10 mg of oral domperidone administered (four times a day) for two weeks | ||
| Oral Domperidone | Drug | Increased to 20 mg four times a day for 2 weeks at the Investigator's discretion | ||
| Oral Domperidone | Drug | Increased to 30 mg four times a day at the Investigator's discretion |
Inclusion Criteria:
Male or female
Age 18 and older
Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation refractory to standard therapy.
Patients must have a comprehensive evaluation (physical exam and also may include EGD, gastric emptying study, as clinically necessary) to eliminate other causes of their symptoms.
Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:
Exclusion Criteria:
History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raman Battish, MD | Contact | 215-537-7400 | Raman.Battish@ctca-hope.com | |
| Jack Medendorp | Contact | 215-537-3160 | Jack.Medendorp@ctca-hope.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Regional Medical Center, Inc. | Available | Philadelphia | Pennsylvania | 19124 | United States |
Not provided
| ID | Term |
|---|---|
| D004294 | Domperidone |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
Not provided
Not provided
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |