Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis
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ClinicalTrials.gov Identifier: NCT01711918 |
Recruitment Status
:
Completed
First Posted
: October 22, 2012
Results First Posted
: December 19, 2016
Last Update Posted
: February 9, 2018
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Condition or disease | Intervention/treatment | Phase |
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Patients With Gastroparesis Who Have Failed Standard Therapy | Drug: Domperidone | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | April 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Domperidone
Participants will received domperidone at a dose of 10mg given up to three times per day
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Drug: Domperidone
oral tablet; dose is 10mg per tablet given up to 3 times daily.
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- Improvement of Overall Symptoms Based on Likert Scale [ Time Frame: Baseline and End of study (2 years or last visit if patient withdraws) ]A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.
- Improvement of Nausea Based on Likert Scale [ Time Frame: Baseline and End of study (2 years or last visit if patient withdraws) ]A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.
- Improvement of Vomiting Based on Likert Scale [ Time Frame: Baseline and End of study (2 years or last visit if patient withdraws) ]A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.
- Improvement of Abdominal Bloating or Distention Based on Likert Scale [ Time Frame: Baseline and End of study (2 years or last visit if patient withdraws) ]A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.
- Improvement of Premature Abdominal Fullness After Meals Based on Likert Scale [ Time Frame: Baseline and End of study (2 years or last visit if patient withdraws) ]A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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, 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
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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 QTc (QTC>450 milliseconds for males, QTc>470 milliseconds for females)
- Clinically significant electrolyte disorders
- Gastrointestinal hemmorrhage 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, 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711918
United States, Iowa | |
University of Iowa Hospitals and Clinics | |
Iowa City, Iowa, United States, 52242 |
Responsible Party: | Ron Schey, Clinical Assistant Professor, University of Iowa |
ClinicalTrials.gov Identifier: | NCT01711918 History of Changes |
Other Study ID Numbers: |
Domperidone |
First Posted: | October 22, 2012 Key Record Dates |
Results First Posted: | December 19, 2016 |
Last Update Posted: | February 9, 2018 |
Last Verified: | February 2018 |
Keywords provided by Ron Schey, University of Iowa:
gastroparesis domperidone nausea vomiting |
Additional relevant MeSH terms:
Nausea Vomiting Gastroparesis Signs and Symptoms, Digestive Signs and Symptoms Stomach Diseases Gastrointestinal Diseases Digestive System Diseases Paralysis Neurologic Manifestations |
Domperidone Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |