GastroparesisNCT02757534
Domperidone for Chronic Nausea and Vomiting
A study testing Domperidone in people with Gastroparesis, run by Yehudith Assouline-Dayan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Domperidone
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis
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).
Read the 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.
- Conditions
- Gastroparesis
- Being tested
- Domperidone
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomperidoneDrug
The study drug will be given to relieve the symptoms of gastroparesis, including nausea and vomiting.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Yehudith Assouline-Dayan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yehudith Assouline-Dayan, University of Iowa
- Investigators
- Yehudith Assouline-Dayan, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757534
- Sponsor's protocol ID
- 201504713
- Status last verified
- May 2020
- First submitted
- 9 Jun 2015
- Last updated
- 5 May 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis
- ClinicalTrials.gov ID
- NCT02757534
- Acronym / sponsor ID
- 201504713
- Conditions
- Gastroparesis
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Yehudith Assouline-DayanUniversity, hospital or other
- First posted
- 2 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DomperidoneThe study drug will be given to relieve the symptoms of gastroparesis, including nausea and vomiting. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yehudith Assouline-Dayan, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Domperidone in people with Gastroparesis, run by Yehudith Assouline-Dayan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.