Domperidone for Chronic Nausea and Vomiting
Primary Purpose
Gastroparesis
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Domperidone
Sponsored by
About this trial
This is an expanded access trial for Gastroparesis
Eligibility Criteria
Inclusion Criteria:
- Male or Female
- Age 18 - 60
- Symptoms or manifestation secondary to gastroparesis such as vomiting, nausea, the feeling you are full after you start eating, bloating and abdominal pain.
- 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.
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
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:
- 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
- Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged corrected QT interval (QTc) (QTc>450 milliseconds for males, QTc>470 milliseconds for females)
- Clinically significant electrolyte disorders
- Hepatic dysfunction
- Renal insufficiency
- Gastrointestinal hemorrhage or obstruction
- Presence of a prolactinoma (prolactin-releasing pituitary tumor)
- Pregnant or breast feeding female
- Known allergy to domperidone
The following medications are prohibited during the study:
- 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®),
- 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®)
- Anti-Emetics: prochlorperazine (Compazine®), thioridazine (Mellaril®), promethazine (Phenergan®), mesoridazine (Serentil®), thiethylperazine, (Torecan®), perphenazine (Trilafon®), dolasetron (Anzemet®), dronabinol (Marinol®), droperidol (Inapsine®)
- 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®)
- Anti-Fungal Agents: fluconazole (Diflucan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), miconazole (Micatin®, Monistat®), terconazole (Terazol®), tioconazole (Vagistat®), butoconazole (Femstat 3®)
- Antivirals: foscarnet (Foscavir®)
- Protease Inhibitors: indinavir (Crixivan®), amprenavir (Agenerase®), ritonavir (Norvir®), nelfinavir (Viracept®), saquinavir (Invirase®, Fortovase®),
- Anti-Hypertensives: nicardipine (Cardene®), isradipine (Dynacirc®), moexipril/ hydrochlorothiazide (HCTZ) (Uniretic®)
- Calcium Channel Blockers: verapamil (Calan®), diltiazem (Cardizem®), diltiazem/enalapril (Teczem®), verapamil/trandolapril (Tarka®), tocainide (Tonocard®), bepridil (Vascor®)
- 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®)
- Diuretics: bumetanide (Bumex®), furosemide (Lasix®), torsemide (Demadex®), ethacrynic Acid (Edecrin®), chlorothiazide (Diuril®), Indapamide (Lozol®)
- Antilipemics: probucol (Lorelco®), Bepridil (Vascor®), mibefradil (Posicor®),
- Hematological Agents: cilostazol (Pletal®)
- Respiratory Agents: zafirlukast (Accolate®), salmeterol (Serevent®)
- Gastrointestinal Agents: cimetidine (Tagamet®), cisapride (Propulsid®)
- Antidiarrheal: octreotide (Sandostatin®)
- Antihistamines: azelastine (Astelin®), clemastine (Tavist®)
- Migraine treatment: naratriptan (Amerge®), sumatriptan (Imitrex®), zolmitriptan (Zomig®)
- Antimalarial: halofantrine
- Muscle relaxants: tizanidine (Zanaflex®)
- Narcotic Dependence: levomethadyl (Orlaam®)
- Miscellaneous: tamoxifen (Nolvadex®), warfarin (Coumadin®), phenytoin (Dilantin®), ziprasidone (Geodon®), risperidone (Risperdal®), formoterol fumarate (Foradil Aerolizer®), sildenafil (Viagra®)
- 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.
Sites / Locations
- University of Iowa
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02757534
Brief Title
Domperidone for Chronic Nausea and Vomiting
Official Title
Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis
Study Type
Expanded Access
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yehudith Assouline-Dayan
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to provide oral domperidone to patients with gastroparesis, between the ages of 18 and 60 years of age, who have failed standard treatment. Standard therapy at the University of Iowa is eating blended foods, liquid diet, Eryped syrup (125 mg TID) 30 minutes before meals, or reglan (20 mg BID).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Domperidone
Intervention Description
The study drug will be given to relieve the symptoms of gastroparesis, including nausea and vomiting.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female
Age 18 - 60
Symptoms or manifestation secondary to gastroparesis such as vomiting, nausea, the feeling you are full after you start eating, bloating and abdominal pain.
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.
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
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:
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
Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged corrected QT interval (QTc) (QTc>450 milliseconds for males, QTc>470 milliseconds for females)
Clinically significant electrolyte disorders
Hepatic dysfunction
Renal insufficiency
Gastrointestinal hemorrhage or obstruction
Presence of a prolactinoma (prolactin-releasing pituitary tumor)
Pregnant or breast feeding female
Known allergy to domperidone
The following medications are prohibited during the study:
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®),
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®)
Anti-Emetics: prochlorperazine (Compazine®), thioridazine (Mellaril®), promethazine (Phenergan®), mesoridazine (Serentil®), thiethylperazine, (Torecan®), perphenazine (Trilafon®), dolasetron (Anzemet®), dronabinol (Marinol®), droperidol (Inapsine®)
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®)
Anti-Fungal Agents: fluconazole (Diflucan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), miconazole (Micatin®, Monistat®), terconazole (Terazol®), tioconazole (Vagistat®), butoconazole (Femstat 3®)
Antivirals: foscarnet (Foscavir®)
Protease Inhibitors: indinavir (Crixivan®), amprenavir (Agenerase®), ritonavir (Norvir®), nelfinavir (Viracept®), saquinavir (Invirase®, Fortovase®),
Anti-Hypertensives: nicardipine (Cardene®), isradipine (Dynacirc®), moexipril/ hydrochlorothiazide (HCTZ) (Uniretic®)
Calcium Channel Blockers: verapamil (Calan®), diltiazem (Cardizem®), diltiazem/enalapril (Teczem®), verapamil/trandolapril (Tarka®), tocainide (Tonocard®), bepridil (Vascor®)
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®)
Diuretics: bumetanide (Bumex®), furosemide (Lasix®), torsemide (Demadex®), ethacrynic Acid (Edecrin®), chlorothiazide (Diuril®), Indapamide (Lozol®)
Antilipemics: probucol (Lorelco®), Bepridil (Vascor®), mibefradil (Posicor®),
Hematological Agents: cilostazol (Pletal®)
Respiratory Agents: zafirlukast (Accolate®), salmeterol (Serevent®)
Gastrointestinal Agents: cimetidine (Tagamet®), cisapride (Propulsid®)
Antidiarrheal: octreotide (Sandostatin®)
Antihistamines: azelastine (Astelin®), clemastine (Tavist®)
Migraine treatment: naratriptan (Amerge®), sumatriptan (Imitrex®), zolmitriptan (Zomig®)
Antimalarial: halofantrine
Muscle relaxants: tizanidine (Zanaflex®)
Narcotic Dependence: levomethadyl (Orlaam®)
Miscellaneous: tamoxifen (Nolvadex®), warfarin (Coumadin®), phenytoin (Dilantin®), ziprasidone (Geodon®), risperidone (Risperdal®), formoterol fumarate (Foradil Aerolizer®), sildenafil (Viagra®)
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yehudith Assouline-Dayan, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Domperidone for Chronic Nausea and Vomiting
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