Domperidone Expanded Access Program for Oncology Patients With Gastroparesis Who Have Failed Standard Therapy

Description

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.

Study Start Date

Not specified

Estimated Completion Date

Not specified

Interventions

  • Drug: Oral Domperidone

Specialties

  • Internal Medicine: Gastroenterology,Hematology/Oncology
  • Nursing: Gastroenterology,Hematology/Oncology
  • Gastroenterology: GI Motility
  • Family Medicine: Gastroenterology
  • Oncology: Pharmacology/Therapy
  • Physician Assistant: Gastroenterology,Hematology/Oncology

MeSH Terms

  • Digestive System Diseases
  • Domperidone
  • Gastroparesis
  • Oncology

Study ID

Eastern Regional Medical Center -- EP2014022

Status

Available

Trial ID

NCT02494687

Study Type

Expanded Access

Trial Phase

N/A

Enrollment Quota

Not Listed

Sponsor

Eastern Regional Medical Center

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Not Listed

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Eastern Regional Medical Center Inc - Philadelphia, Pennsylvania 127.9 miles Raman Battish MD 215-537-7400 Raman.Battish@ctca-hope.com

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