Domperidone for the Treatment of Chronic Nausea and Vomiting Secondary to Gastroparesis

• Sponsor: Ron Schey (Other)
• Overall Status: Completed
• CT.gov ID: NCT01711918
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Duration (Months): 21
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patients With Gastroparesis Who Have Failed Standard Therapy	Drug: Domperidone	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• 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: Jul 1, 2012
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Domperidone Participants will received domperidone at a dose of 10mg given up to three times per day	Drug: Domperidone; oral tablet; dose is 10mg per tablet given up to 3 times daily.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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'.

2. 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'.

3. 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'.

4. 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'.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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:

7. surgically sterile (have had a hysterectomy or bilateral oophorectomy, or tubal ligation)

8. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• Ron Schey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ron Schey, Clinical Assistant Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT01711918
• Other Study ID Numbers: Domperidone
• First Posted: Oct 22, 2012
• Last Update Posted: Feb 9, 2018
• Last Verified: Feb 1, 2018

• Keywords provided by Ron Schey, Clinical Assistant Professor, University of Iowa: gastroparesis; domperidone; nausea; vomiting
• Additional relevant MeSH terms: Gastroparesis; Nausea; Vomiting; Domperidone

Study Results

Participant Flow

Arm/Group Title	Domperidone
Arm/Group Description	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.
Period Title: Overall Study
STARTED	9
COMPLETED	7
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Domperidone
Arm/Group Description	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.
Overall Participants	9
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33 (10.5)
Sex: Female, Male (Count of Participants)
Female	8 88.9%
Male	1 11.1%
Region of Enrollment (participants) [Number]
United States	9 100%

Outcome Measures

1. Primary Outcome

Title	Improvement of Overall Symptoms Based on Likert Scale
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Domperidone
Arm/Group Description	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.
Measure Participants	7
Count of Participants [Participants]	2 22.2%

2. Secondary Outcome

Title	Improvement of Nausea Based on Likert Scale
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Domperidone
Arm/Group Description	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.
Measure Participants	7
Count of Participants [Participants]	2 22.2%

3. Secondary Outcome

Title	Improvement of Vomiting Based on Likert Scale
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Domperidone
Arm/Group Description	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.
Measure Participants	7
Count of Participants [Participants]	2 22.2%

4. Secondary Outcome

Title	Improvement of Abdominal Bloating or Distention Based on Likert Scale
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Domperidone
Arm/Group Description	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.
Measure Participants	7
Count of Participants [Participants]	2 22.2%

5. Secondary Outcome

Title	Improvement of Premature Abdominal Fullness After Meals Based on Likert Scale
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Domperidone
Arm/Group Description	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.
Measure Participants	7
Count of Participants [Participants]	1 11.1%

Adverse Events

Arm/Group Title	Domperidone
Arm/Group Description	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.
All Cause Mortality
	Domperidone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Domperidone
	Affected / at Risk (%)	# Events
Total	0/7 (0%)
Other (Not Including Serious) Adverse Events
	Domperidone
	Affected / at Risk (%)	# Events
Total	5/7 (71.4%)
Blood and lymphatic system disorders
Hypophosphatemia	1/7 (14.3%)	1
Cardiac disorders
Chest Palpitations	1/7 (14.3%)	1
Ear and labyrinth disorders
Dizziness	1/7 (14.3%)	1
Gastrointestinal disorders
Partial Bowel Obstruction	1/7 (14.3%)	1
Abdominal Pain	1/7 (14.3%)	1
Heartburn	1/7 (14.3%)	1
General disorders
Dry Mouth	1/7 (14.3%)	1
Hepatobiliary disorders
Elevated ALT	1/7 (14.3%)	1
Elevated AST	1/7 (14.3%)	1
Musculoskeletal and connective tissue disorders
Back Pain	1/7 (14.3%)	1
Shaking	1/7 (14.3%)	1
Chest Pain	1/7 (14.3%)	1
Shoulder Pain	1/7 (14.3%)	1
Nervous system disorders
Migraine	1/7 (14.3%)	1
Headache	1/7 (14.3%)	1
Hand Tingling	1/7 (14.3%)	1
Reproductive system and breast disorders
Ruptured Right Ovarian Cyst	1/7 (14.3%)	1
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection	2/7 (28.6%)	3
Shortness of Breath	1/7 (14.3%)	1
Skin and subcutaneous tissue disorders
Allergic Reaction	1/7 (14.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.