Domperidone in Refractory Gastroparesis

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-07-31

Brief Summary

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The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.

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Detailed Description

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Conditions

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Gastroparesis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Domperidone

Group Type OTHER

Domperidone

Intervention Type DRUG

10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily

Interventions

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Domperidone

10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female
* Age 18 and older
* Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
* Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.
* Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

* Increased prolactin levels
* Breast changes
* Extrapyramidal side effects
* Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)

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.
* Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc\>450 milliseconds for males, QTc\>470 milliseconds for females)
* Clinically significant electrolyte disorders. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.
* Gastrointestinal hemorrhage or obstruction.
* Presence of a prolactinoma (prolactin-releasing pituitary tumor).
* Pregnant or breast feedings female.
* Known allergy to domperidone

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No