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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after completion of study treatment
Awards & highlights

Study Summary

This trial looks at how well domperidone works to treat gastrointestinal disorders. Domperidone may help control symptoms like pain, bloating, and nausea and vomiting, by stimulating the stomach to empty itself of food.

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.Check my eligibility
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.See study design
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
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I have severe stomach or esophagus problems like gastroparesis, GERD, or dyspepsia.
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My GI disorder hasn't improved with standard treatments.
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I have agreed to take the study drug, domperidone, by signing a consent form.
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I have severe stomach or esophagus problems, like gastroparesis or bad heartburn.
Select...
I have severe stomach issues like gastroparesis, GERD, or dyspepsia.
Select...
My GI disorder hasn't improved with standard treatments.
Select...
My GI disorder hasn't improved with standard treatments.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Attenuation of symptoms associated with disorder(s) of gastrointestinal motility, measured by change in Gastroparesis Cardinal Symptom Index (GSCI) score from baseline
Secondary outcome measures
Change in patients' self-report of symptoms
Incidence of toxicities assessed according to the Common Terminology Criteria for Adverse Events version 4.0

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

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,165 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,195 Total Patients Enrolled
Mehnaz ShafiPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
284 Total Patients Enrolled

Media Library

Domperidone (Prokinetic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01696734 — Phase 3
Gastroparesis Research Study Groups: Treatment (domperidone)
Gastroparesis Clinical Trial 2023: Domperidone Highlights & Side Effects. Trial Name: NCT01696734 — Phase 3
Domperidone (Prokinetic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01696734 — Phase 3
Gastroparesis Patient Testimony for trial: Trial Name: NCT01696734 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any documented dangers of taking Domperidone?

"Domperidone's Phase 3 status signifies that, while there is some efficacy data, the drug has undergone multiple rounds of testing for safety. Therefore, our team at Power has given it a score of 3 for safety."

Answered by AI

Could you inform me as to how many people are included in this experiment?

"That is accurate. The clinical trial was first posted on October 23, 2012 and is still actively recruiting patients, as indicated by the most recent edit on October 18, 2022. They are looking for 200 participants total, at a single location."

Answered by AI

Are there other examples of research regarding Domperidone?

"There are 4 ongoing studies evaluating Domperidone's efficacy. 1 of those trials is in the final stage of testing, Phase 3. The remaining trials are based in Bangkok, but there are 4 locations total running these studies."

Answered by AI

For what therapeutic reasons is Domperidone typically prescribed?

"Domperidone is used to treat a variety of upper gastrointestinal motility disorders, including gastroparesis, esophagitis, and gastroesophageal reflux disease."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Texas
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
2

What questions have other patients asked about this trial?

How far along are you in this trial? When do you think you may get it FDA approved?
PatientReceived no prior treatments
How long is the trial for? What phase is the trial in? Will there be placebos given in this trial?
PatientReceived no prior treatments

Why did patients apply to this trial?

I’ve tried numerous medications and have had the G-Poem procedure and am still having gastroparesis symptoms regularly.
PatientReceived no prior treatments
Want to improve my Gastroparesis so I can eat again. I have lost 50 pounds and I am on a feeding tube. Being able to eat solid foods again would be amazing.
PatientReceived 1 prior treatment
I have been dealing with this for over a year and my doctors really have no idea how to treat it. I am unable to make plans as I am not sure I will feel well enough to go, I would like to not only get some relief from this condition, but hopefully can help others as well. We need help.
PatientReceived 1 prior treatment
~24 spots leftby Oct 2025