- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01711918
Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis
February 7, 2018 updated by: Ron Schey
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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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oral tablet; dose is 10mg per tablet given up to 3 times daily.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of Overall Symptoms Based on Likert Scale
Time Frame: Baseline and End of study (2 years or last visit if patient withdraws)
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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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Baseline and End of study (2 years or last visit if patient withdraws)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of Nausea Based on Likert Scale
Time Frame: Baseline and End of study (2 years or last visit if patient withdraws)
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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'.
|
Baseline and End of study (2 years or last visit if patient withdraws)
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Improvement of Vomiting Based on Likert Scale
Time Frame: Baseline and End of study (2 years or last visit if patient withdraws)
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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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Baseline and End of study (2 years or last visit if patient withdraws)
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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)
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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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Baseline and End of study (2 years or last visit if patient withdraws)
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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)
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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'.
|
Baseline and End of study (2 years or last visit if patient withdraws)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
October 18, 2012
First Submitted That Met QC Criteria
October 18, 2012
First Posted (Estimate)
October 22, 2012
Study Record Updates
Last Update Posted (Actual)
February 9, 2018
Last Update Submitted That Met QC Criteria
February 7, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neurologic Manifestations
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Stomach Diseases
- Paralysis
- Nausea
- Vomiting
- Gastroparesis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Dopamine Agents
- Dopamine Antagonists
- Domperidone
Other Study ID Numbers
- Domperidone
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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