Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis

Inclusion Criteria:

1. Male or Female

2. Age 18 - 60

3. Symptoms or manifestation secondary to gastroparesis such as vomiting, nausea, the
feeling you are full after you start eating, and abdominal pain.

4. Subjects must have a comprehensive evaluation to eliminate other causes of their
symptoms which includes gastric emptying scintigraphy, esophagogastroduodenoscopy
(EGD), and the patient's subjective symptoms.

5. Subject has signed informed consent for the administration of domperidone that informs
the patient of potential adverse events

6. Female subjects must be:

1. surgically sterile (have had a hysterectomy or bilateral oophorectomy, or tubal
ligation)

2. if sexual active, practicing an effective method of birth control such as
hormonal prescription oral contraceptives, progesterone implants or injections,
contraceptive patch, intrauterine device, or maintenance of a monogamous
relationship with a male partner who has been surgically sterilized by vasectomy.
A double barrier method such as condoms, diaphragms, or cervical caps with
spermicidal foam, cream, or gel may be used as a method of birth control

Exclusion Criteria:

1. History of, or current, arrhythmias including ventricular tachycardia, ventricular
fibrillation, atrial fibrilation and Torsade des Pointes, subjects with minor forms of
ectopy (PACs) are not necessarily excluded

2. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged
QTc (QTC>450 milliseconds for males, QTc>470 milliseconds for females)

3. Clinically significant electrolyte disorders

4. Gastrointestinal hemmorrhage or obstruction

5. Presence of a prolactinoma (prolactin-releasing pituitary tumor)

6. Pregnant or breast feeding female

7. Known allergy to domperidone The following medications are prohibited during the
study: antidepressants: doxepin, clomipramine, amopxapine, trazodone, venlafaxine,
nefazodone, fluvoxamine, paroxetine, fluoxetine, sertraline, amitriptyline,
maprotiline, desipramine, nortriptyline, trimipramine, imipramine, protriptyline;
anti-psychotics: haloperidol, chlorpromazine, chlorpromazine pimozide, sertindole,
quetiapine, mesoridazine, perphenazine, lfluphenazine, promazine, trifluoperazine;
anti-emetics: prochlorperazine, thioridazine, promethazine, mesoridazine,
theiethylperazine, perphazine, dolasetron, dronabinol, droperidol; anti-infective
agents: erythromycin, clarithromycin, troleandomycin, norfloxcin, quinine sulfate,
quinupristin and dalfopristin, pentamidine, sparfloxacin, grepafloxacin, azithromycin,
ofloxacin, levofloxacin; anti-fungal agents: fluconazole, itraconazole, ketoconazole,
miconazole, terconazole, ticonazole, butaconazole; antivirals: foscarnet; protease
inhibitors: indinavir, amprenavir, ritonavir, nelfinavir, squinavir;
antihypertensives: nicardipine, isradipine, moexipril/HCTZ; calcium channel blockers:
verapamil, diltiazem, deltiazem/enalapril, verapamil/trandolapril, tocainide,
bepridil; anti-arrhythmics: disopyramide, quinidine, procainamide, flecainide,
sotalol, bretylium, amiodarone, ibutilide, moricizine; diueretics: bumetanide,
furosemide, torsemide, etharcrynic acid, chlorothiazide, indapamide; antilipemics:
probucol, bepridil, mibefradil; hematological agents: cilostazol; respiratory agents:
zafirlukast, salmetrol; gastrointestinal agents: cimetidine, cisapride; antidiarrheal:
octreotide; antihistamines: azelastine, clemastine; migraine treatment: naratriptan,
sumatriptan, zolmitriptan; antimalarial: halofantrine; muscle relaxants: tizanidine;
narcotic dependence: levomethadyl; miscellaneous: tamoxifen, warfarin, phenytoin,
ziprasidone, risperidone, formoterol fumarate, sildenafil; drugs that prolong the QT
Interval: albuterol, alfuzosin, amantadine, amisulpride, amphetamine, arsenic
trioxide, astemizole, atazanavir, atomoxetine, chloral hydrate, chloroquine,
ciprofloxacin, citalopram, clozapine, cocaine, dexmethylphenidate, diphenhydramine,
dobutamine, dofetilide, dopamine, dronedarone, ephedrine, epinephrine, eribulin,
escitalopram, famotidine, felbamate, fenfluramine, fingolimod, fosphenytoin,
galantamine, gatifloxacin, gemifloxacin, granisetron, iloperidone, isoproterenol,
lapatinib, levalbuterol, lisdexamfetamine, lithium, metaproterenol, methadone,
methylphenidate, midodrine, moxifloxacin, nilotinib, norepinephrine, ondansetron,
oxytocin, paliperidone, perflutren lipid microspheres, phentermine, phenylephrine,
phenylpropanolamine, protriptyline, pseudoephedrine, ranolazine, ritodrine,
toxithromycin, sibutramine, solifenacin, sunitinib, tacrolimus, telithromycin,
terbutaline, terfenadine, tolterodine, trimethoprim-sulfa, vandetanib, vardenafil,
voriconazole.