Domperidone Expanded Access Program for Oncology Patients With Gastroparesis Who Have Failed Standard Therapy
| Status: | Available |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/27/2018 |
| Contact: | Raman Battish, MD |
| Email: | Raman.Battish@ctca-hope.com |
| Phone: | 215-537-7400 |
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.
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.
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.
Inclusion Criteria:
1. Male or female
2. Age 18 and older
3. 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.
4. 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.
5. Patient has signed informed consent for the administration of domperidone that informs
the patient of potential adverse events including:
- increased prolactin levels
- extrapyramidal side-effects
- breast changes
- cardiac arrhythmias including QT prolongation and death
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.
1. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged
QTc (QTc> 450 milliseconds for males, QTc>470 milliseconds for females).
2. Clinically significant electrolyte disorders.
3. Gastrointestinal hemorrhage or obstruction
4. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
5. Pregnant or breast feeding female
6. Known allergy to domperidone
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