Domperidone for Chronic Nausea and Vomiting

This is a compassionate use research study for a non-FDA approved drug. We are inviting
patients to participate in this research study because they have nausea and vomiting related
to gastroparesis and have failed standard therapy. The purpose of this research study is to
prescribe patients with domperidone. Domperidone is considered investigational, which means
that it has not been approved by the FDA.

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, bloating 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 including:

- increased prolactin levels

- extrapyramidal side effects

- breast changes

- cardiac arrhythmias including QT prolongation and death

6. Female subjects must be:

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

- 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
corrected QT interval (QTc) (QTc>450 milliseconds for males, QTc>470 milliseconds for
females)

3. Clinically significant electrolyte disorders

4. Hepatic dysfunction

5. Renal insufficiency

6. Gastrointestinal hemorrhage or obstruction

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

8. Pregnant or breast feeding female

9. Known allergy to domperidone

The following medications are prohibited during the study:

1. Antidepressants: doxepin (Adapin®, Sinequan®, Zonalon®), clomipramine (Anafranil®),
amoxapine (Asendin®), trazodone (Desyrel®), venlafaxine (Effexor®), nefazodone
(Serzone®), fluvoxamine (Luvox®), paroxetine (Paxil®), fluoxetine (Prozac®, Sarafem®),
nefazodone (Serzone®), sertraline (Zoloft®), amitriptyline (Elavil®, Endep®, Etrafon®,
Limbitrol®, Triavil®), maprotiline (Ludiomil®), desipramine (Norpramin®),
nortriptyline (Pamelor®), trimipramine (Surmontil®), imipramine (Tofranil®),
protriptyline (Vivactil®),

2. Anti-psychotics: haloperidol (Haldol®), chlorpromazine (Thorazine®, Ormazine®),
chlorpromazine pimozide (Orap®), sertindole (Serlect®), quetiapine (Seroquel®),
mesoridazine (Serentil®), perphenazine (Triavil®), fluphenazine (Apo-Fluphenazine®,
Modecate Concentrate®, Moditen®, Permitil®, phenazine methosulfate-Fluphenazine®,
Prolixin®, Rho-Fluphenazine®), promazine (Sparine®), trifluoperazine (Stelazine®)

3. Anti-Emetics: prochlorperazine (Compazine®), thioridazine (Mellaril®), promethazine
(Phenergan®), mesoridazine (Serentil®), thiethylperazine, (Torecan®), perphenazine
(Trilafon®), dolasetron (Anzemet®), dronabinol (Marinol®), droperidol (Inapsine®)

4. Anti-infective agents: erythromycin (such as E.E.S.®, E-Mycin®, Ilotycin® ,
Pediazole®, Akne-mycin®), clarithromycin (Biaxin®), troleandomycin (TAO®), norfloxacin
(Ciproxin®, Noroxin®), quinine sulfate, quinupristin and dalfopristin (Synercid®),
pentamidine (Nebupent®, Pentacarinat®, Pentam®), sparfloxacin (Zagam®), grepafloxacin
(Raxar®), azithromycin (Zithromax®), ofloxacin (Floxin®). Levofloxacin (Levaquin®)

5. Anti-Fungal Agents: fluconazole (Diflucan®), itraconazole (Sporanox®), ketoconazole
(Nizoral®), miconazole (Micatin®, Monistat®), terconazole (Terazol®), tioconazole
(Vagistat®), butoconazole (Femstat 3®)

6. Antivirals: foscarnet (Foscavir®)

7. Protease Inhibitors: indinavir (Crixivan®), amprenavir (Agenerase®), ritonavir
(Norvir®), nelfinavir (Viracept®), saquinavir (Invirase®, Fortovase®),

8. Anti-Hypertensives: nicardipine (Cardene®), isradipine (Dynacirc®), moexipril/
hydrochlorothiazide (HCTZ) (Uniretic®)

9. Calcium Channel Blockers: verapamil (Calan®), diltiazem (Cardizem®),
diltiazem/enalapril (Teczem®), verapamil/trandolapril (Tarka®), tocainide (Tonocard®),
bepridil (Vascor®)

10. Anti-Arrhythmics: disopyramide (Norpace®, Norpace Controlled Release ®), quinidine
(such as Quinidex®, Cardioquin®, Quinaglute®, Duraquin®), procainamide (Procanbid® ,
Procan®, Pronestyl®,), flecainide (Tambocor®), sotalol (Betapace®), bretylium
(Bretylol®), amiodarone (Cordarone®), ibutilide (Corvert®), moricizine (Ethmozine®)

11. Diuretics: bumetanide (Bumex®), furosemide (Lasix®), torsemide (Demadex®), ethacrynic
Acid (Edecrin®), chlorothiazide (Diuril®), Indapamide (Lozol®)

12. Antilipemics: probucol (Lorelco®), Bepridil (Vascor®), mibefradil (Posicor®),

13. Hematological Agents: cilostazol (Pletal®)

14. Respiratory Agents: zafirlukast (Accolate®), salmeterol (Serevent®)

15. Gastrointestinal Agents: cimetidine (Tagamet®), cisapride (Propulsid®)

16. Antidiarrheal: octreotide (Sandostatin®)

17. Antihistamines: azelastine (Astelin®), clemastine (Tavist®)

18. Migraine treatment: naratriptan (Amerge®), sumatriptan (Imitrex®), zolmitriptan
(Zomig®)

19. Antimalarial: halofantrine

20. Muscle relaxants: tizanidine (Zanaflex®)

21. Narcotic Dependence: levomethadyl (Orlaam®)

22. Miscellaneous: tamoxifen (Nolvadex®), warfarin (Coumadin®), phenytoin (Dilantin®),
ziprasidone (Geodon®), risperidone (Risperdal®), formoterol fumarate (Foradil
Aerolizer®), sildenafil (Viagra®)

23. 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, roxithromycin, sibutramine, solifenacin, sunitinib, tacrolimus,
telithromycin, terbutaline, terfenadine, tolterodine, trimethoprim-sulfa, vandetanib,
vardenafil, voriconazole.