Clinical trial NCT01378884: The Use of Domperidone for Gastroparesis
Official title: Monitoring Study for the Use of Gastroparesis for Patient Who Have Failed Standard Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Gastroparesis
Keywords: Gastroparesis
Domperidone
Motilium
Lead sponsor: Allegiance Health
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether domperidone can be used safely and effectively for patient with gastroparesis.

Detailed description: Individuals who have been diagnosed with gastroparesis and have failed at least one standard therapy will be offered to trial domperidone as a possible remedy to their condition. Patients on the medication will be expected to to be followed by the physician at 3 months, 6 months 12months, and then annually while on the medication. Any change or significant adverse reaction to the medication or in their condition should be reported immediately to their physician.

Eligibility criteria: Inclusion Criteria:

1. Male or female
2. Age 18 or 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 that are refractory to standard therapy.
4. Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms.
5. Subject has signed informed consent for the administration of domperidone. The informed consent informs the subject of potential adverse events including:

   * increased prolactin levels,
   * extrapyramidal side effects,
   * breast changes,
   * cardiac arrhythmias including QT prolongation, and

Exclusion Criteria:

1. History of or current cardiac disease, including ischemic or valvular heart disease, other structural heart defects, cardiomyopathy or congestive heart failure.
2. History of or current arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Subjects with minor forms of ectopy (PACs) are not necessarily excluded.
3. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QT syndrome (QTc greater than 450 milliseconds for males, greater 470 milliseconds for females) or family history prolonged QT syndrome.
4. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
5. Conditions that result in electrolyte disorders, such as severe dehydration, vomiting, malnutrition, eating disorders, renal diseases, or the use of potassium-wasting diuretics or insulin in acute settings. (Note that the presence of vomiting, that may accompany gastroparesis or pseudo-obstruction does not by itself exclude the subject - only if accompanied by electrolyte disturbance must the subject be excluded.)
6. Pregnant or breast feeding female.
7. Known allergy to domperidone or any components of the domperidone formulation.
8. Significantly significant electrolyte disorders.
9. Gastrointestinal hemorrhage or obstruction.

Primary outcomes:
measure: Improved Gastric motility
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Allegiance Health Gastroenterology
name: Ivan Cubas, MD
role: PRINCIPAL_INVESTIGATOR
References: