Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis
Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis
To provide oral domperidone to patients between the ages of 18 and 60 years of age, according
 to the investigator's judgment, a prokinetic effect is needed for the relief of severe
 gastroparesis. We have defined severe gastroparesis as 1) positive gastric emptying
 scintigraphy (more than 10% residue at 4 hours), 2) nausea, 3) early satiety, 4) abdominal
 pain. We will recruit patients for two years and the patients will be given domperidone for
 up to two years.
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.