Domperidone for Chronic Nausea and Vomiting

NCT02757534 | Unknown

• 1 other identifier: 201504713
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Gastroparesis

Interventions

Domperidone DRUG

The study drug will be given to relieve the symptoms of gastroparesis, including nausea and vomiting.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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®)

Sponsors & Collaborators

• Yehudith Assouline-Dayan: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

Domperidone

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yehudith Assouline-Dayan, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: May 2, 2016
• Last Updated: May 5, 2020

Record last verified: 2020-05

Locations

US (1)