Domperidone in Refractory Gastroparesis

• Sponsor: Yale University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00760461
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arm: 1
• Duration (Months): 33
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The primary objective of this study is to prescribe oral domperidone for patients with gastroparesis who have failed or suffered adverse effects from standard medical therapy.

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis	Drug: Domperidone	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Domperidone in Refractory Gastroparesis
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Domperidone	Drug: Domperidone; 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily

Outcome Measures

Primary Outcome Measures

1. Gastroparesis Cardinal Symptom Index [upon study completion]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female

• Age 18 and older

• Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.

• Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.

• Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

• Increased prolactin levels

• Breast changes

• Extrapyramidal side effects

• Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)

Exclusion Criteria:

• History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients 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. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.

• Gastrointestinal hemorrhage or obstruction.

• Presence of a prolactinoma (prolactin-releasing pituitary tumor).

• Pregnant or breast feedings female.

• Known allergy to domperidone

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale Digestive Diseases 40 Temple St, Suite 1A	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

• Yale University

Investigators

• Principal Investigator: Anish A Sheth, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00760461
• Other Study ID Numbers: 0809004202
• First Posted: Sep 26, 2008
• Last Update Posted: Aug 18, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Gastroparesis; Domperidone

Study Results

Participant Flow

Arm/Group Title	Domperidone
Arm/Group Description	Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
Period Title: Overall Study
STARTED	44
COMPLETED	0
NOT COMPLETED	44

Baseline Characteristics

Arm/Group Title	Domperidone
Arm/Group Description	Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
Overall Participants	44
Age (Count of Participants)
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male (Count of Participants)
Female	35 79.5%
Male	9 20.5%

Outcome Measures

1. Primary Outcome

Title	Gastroparesis Cardinal Symptom Index
Time Frame	upon study completion

Outcome Measure Data

Analysis Population Description

Data cannot be summarized or analyzed due to the lack of data being collected on the primary outcome due to the trial being terminated.

Arm/Group Title	Domperidone
Arm/Group Description	Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
Measure Participants	0

Adverse Events

Arm/Group Title	Domperidone
Arm/Group Description	Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
All Cause Mortality
	Domperidone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Domperidone
	Affected / at Risk (%)	# Events
Total	0/44 (0%)
Other (Not Including Serious) Adverse Events
	Domperidone
	Affected / at Risk (%)	# Events
Total	0/44 (0%)

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.