What is the mechanism of action of this treatment?

Common treatments for gastroparesis include prokinetic agents like domperidone and erythromycin, which stimulate stomach contractions to enhance gastric emptying. Domperidone works by blocking dopamine receptors, thereby increasing gastrointestinal motility, while erythromycin mimics the action of motilin, a hormone that stimulates gastric contractions. For refractory cases, gastric electrical stimulation and endoscopic pyloromyotomy are used; these methods improve gastric emptying by electrically stimulating the stomach muscles or surgically modifying the pylorus. These treatments are essential for gastroparesis patients as they directly address the impaired gastric motility, reducing symptoms such as nausea and vomiting.

What side effects are associated with this type of intervention?

Common treatments for gastroparesis include prokinetic agents like domperidone and metoclopramide, as well as antibiotics like erythromycin. Domperidone can cause side effects such as dry mouth, abdominal cramps, and, rarely, cardiac arrhythmias due to QT interval prolongation. Metoclopramide is associated with side effects like drowsiness, fatigue, and more serious risks such as tardive dyskinesia, a potentially irreversible movement disorder. Erythromycin can lead to gastrointestinal disturbances, including nausea, vomiting, and abdominal pain. Gastric electrical stimulation, used for refractory cases, may cause surgical complications, infection, and device-related issues such as lead dislodgement.

What prior FDA approvals exist?

The FDA has approved several prokinetic agents for the treatment of gastroparesis. Metoclopramide is the only FDA-approved medication specifically for gastroparesis, which works by stimulating stomach muscle contractions to enhance gastric emptying. Other drugs like erythromycin, although not FDA-approved for gastroparesis, are used off-label due to their prokinetic properties. Domperidone, which is being studied for its efficacy in treating gastroparesis by increasing gastric motility, is not FDA-approved in the United States but is available in other countries.

What other types of research exist?

Promising, novel alternatives to Domperidone for treating gastroparesis include gastric peroral endoscopic pyloromyotomy, gastric electrical stimulation, and intrapyloric botulinum toxin injection. These treatments have demonstrated efficacy in clinical trials and offer new options for managing gastroparesis.

← Back to Search

Prokinetic Agent

Domperidone for Gastrointestinal Disorders

Phase 3

Recruiting

Led By Mehnaz Shafi

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptoms or manifestations of: a) gastroparesis; b) refractory gastroesophageal reflux disease (GERD) including persistent esophagitis, refractory heartburn, reflux-related laryngitis, and respiratory symptoms; or c) severe dyspepsia

Patients with GI disorders who have failed standard therapy

Must not have

Patients who are receiving antiarrhythmic medications with action on repolarization times (with prolongation of the QTc interval such as amiodarone, disopyramide, dofetilide, flecainide, ibutilide, quinidine, sotalol, dronedarone etc.)

Patients with a history of or active liver failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after completion of study treatment

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial studies how well domperidone works in treating patients aged 16 and older with gastrointestinal disorders. Domperidone helps the stomach move food more effectively by making its muscles contract. This can reduce symptoms like pain, bloating, nausea, and vomiting.

Who is the study for?

This trial is for patients with chronic gastrointestinal disorders like gastroparesis, severe heartburn, or indigestion that haven't improved with standard treatments. They must have stable blood counts and organ function, no other causes for their symptoms after a full check-up, and agree to the study's terms. It's not open to pregnant women, those on certain heart drugs or MAO inhibitors, people allergic to domperidone, or anyone with specific heart conditions or severe liver issues.

What is being tested?

The trial is testing how effective domperidone is in treating chronic gastrointestinal disorders by seeing if it can help control symptoms such as pain, bloating, nausea and vomiting. This involves taking the medication and completing questionnaires about symptom changes.

What are the potential side effects?

Domperidone may cause side effects including dry mouth, abdominal cramps, dizziness; it might also affect heartbeat rhythm (QT interval prolongation) which could be serious. Other less common side effects include headache and trouble sleeping.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have severe stomach issues like gastroparesis, GERD, or dyspepsia.

Select...

My GI disorder hasn't improved with standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am taking medication that affects my heart's rhythm.

Select...

I have a history of or currently have liver failure.

Select...

I have a history of serious heart conditions.

Select...

I have a tumor in my pituitary gland that releases prolactin.

Select...

I am currently taking MAO inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 30 days after completion of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 30 days after completion of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 30 days after completion of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Attenuation of symptoms associated with disorder(s) of gastrointestinal motility, measured by change in Gastroparesis Cardinal Symptom Index (GSCI) score from baseline

Secondary study objectives

Change in patients' self-report of symptoms

Incidence of toxicities assessed according to the Common Terminology Criteria for Adverse Events version 4.0

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (domperidone)Experimental Treatment2 Interventions

Patients receive domperidone PO TID or QID. Treatment continues in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Domperidone

2011

Completed Phase 4

~401020

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for gastroparesis include prokinetic agents like domperidone and erythromycin, which stimulate stomach contractions to enhance gastric emptying. Domperidone works by blocking dopamine receptors, thereby increasing gastrointestinal motility, while erythromycin mimics the action of motilin, a hormone that stimulates gastric contractions. For refractory cases, gastric electrical stimulation and endoscopic pyloromyotomy are used; these methods improve gastric emptying by electrically stimulating the stomach muscles or surgically modifying the pylorus. These treatments are essential for gastroparesis patients as they directly address the impaired gastric motility, reducing symptoms such as nausea and vomiting.

Oesophageal and gastric motility disorders in patients categorised as having primary anorexia nervosa.Human antroduodenal motility, pyloric closure, and domperidone.Effect of Phoneutria nigriventer spider venom on gastric emptying in rats.