Domperidone in Refractory Gastroparesis

NCT00760461 | Terminated Phase 2 Results

• 1 other identifier: 0809004202
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Gastroparesis Cardinal Symptom Index

  upon study completion

Study Arms (1)

Domperidone

OTHER

Drug: Domperidone

Interventions

Domperidone DRUG

10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily

Domperidone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Digestive Diseases 40 Temple St, Suite 1A

New Haven, Connecticut, 06510, 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

Results Point of Contact

• Title: Anish A Sheth M.D
• Organization: Yale University

anish.sheth@yale.edu

203-785-4576

Study Officials

• Anish A Sheth, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 26, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 18, 2017
• Results First Posted: August 18, 2017

Record last verified: 2017-02

Locations

US (1)