Patients With Gastroparesis Who Have Failed Standard Therapy
Conditions
Keywords
gastroparesis, domperidone, nausea, vomiting
Brief summary
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.
Interventions
DRUGDomperidone
oral tablet; dose is 10mg per tablet given up to 3 times daily.
Sponsors
Ron Schey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Male or Female 2. Age 18 - 60 3. Symptoms or manifestation secondary to gastroparesis such as vomiting, nausea, the feeling you are full after you start eating, and abdominal pain. 4. 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. 5. Subject has signed informed consent for the administration of domperidone that informs the patient of potential adverse events 6. Female subjects must be: 1. surgically sterile (have had a hysterectomy or bilateral oophorectomy, or tubal ligation) 2. 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
1. 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 2. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTC\>450 milliseconds for males, QTc\>470 milliseconds for females) 3. Clinically significant electrolyte disorders 4. Gastrointestinal hemmorrhage or obstruction 5. Presence of a prolactinoma (prolactin-releasing pituitary tumor) 6. Pregnant or breast feeding female 7. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Overall Symptoms Based on Likert Scale | 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'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Nausea Based on Likert Scale | 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 | 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 | 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 | 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'. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Domperidone Participants will received domperidone at a dose of 10mg given up to three times per day
Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Domperidone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 33 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Improvement of Overall Symptoms Based on Likert Scale
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'.
Time frame: Baseline and End of study (2 years or last visit if patient withdraws)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Domperidone | Improvement of Overall Symptoms Based on Likert Scale | 2 Participants |
Secondary
Improvement of Abdominal Bloating or Distention Based on Likert Scale
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'.
Time frame: Baseline and End of study (2 years or last visit if patient withdraws)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Domperidone | Improvement of Abdominal Bloating or Distention Based on Likert Scale | 2 Participants |
Secondary
Improvement of Nausea Based on Likert Scale
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'.
Time frame: Baseline and End of study (2 years or last visit if patient withdraws)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Domperidone | Improvement of Nausea Based on Likert Scale | 2 Participants |
Secondary
Improvement of Premature Abdominal Fullness After Meals Based on Likert Scale
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'.
Time frame: Baseline and End of study (2 years or last visit if patient withdraws)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Domperidone | Improvement of Premature Abdominal Fullness After Meals Based on Likert Scale | 1 Participants |
Secondary
Improvement of Vomiting Based on Likert Scale
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'.
Time frame: Baseline and End of study (2 years or last visit if patient withdraws)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Domperidone | Improvement of Vomiting Based on Likert Scale | 2 Participants |