Recruiting

Domperidone for Gastrointestinal Motility Disorders

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Study Aim

This study aims to evaluate whether domperidone can reduce symptoms in people with gastrointestinal motility disorders by measuring changes in their symptom scores.

What is being tested

Domperidone

+ Questionnaire Administration

DrugOther
Who is being recruted

Deglutition Disorders+16

+ Esophageal Diseases

+ Gastroenteritis

Over 16 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Phase 3
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Study ContactMehnaz ShafiMore contacts
Last updated: April 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 23, 2012

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. To provide treatment with domperidone to patients >= 16 years of age where, according to the investigators' judgment, a prokinetic effect is needed for the relief of gastrointestinal (GI) motility disorders. OUTLINE: Patients receive domperidone orally (PO) thrice daily (TID) or four times daily (QID). Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for at least 30 days.

NCT01696734
Principal SponsorM.D. Anderson Cancer Center
Study ContactMehnaz ShafiMore contacts
Last updated: April 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Deglutition DisordersEsophageal DiseasesGastroenteritisGastrointestinal DiseasesNeurologic ManifestationsParalysisSigns and SymptomsSigns and Symptoms, DigestiveStomach DiseasesPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDigestive System DiseasesDyspepsiaEsophagitisGastroesophageal RefluxHeartburnNauseaVomitingGastroparesis

Criteria

14 inclusion criteria required to participate
Alanine aminotransferase (ALT) less than 2 x upper limit of normal
Alkaline phosphatase less than 1.5 x upper limit of normal
Aspartate aminotransferase (AST) less than 2 x upper limit of normal
Bilirubin less than or equal to 2 x upper limit of normal
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9 exclusion criteria prevent from participating
Clinically significant electrolyte disorders including sodium < 130 or > 145 and/or potassium < 3.0 or > 5.5 and/or magnesium < 1.6 or > 2.6
GI hemorrhage or obstruction experienced within the previous 6 weeks
Known allergy to domperidone
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.)
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

M D Anderson Cancer Center

Houston, United StatesOpen M D Anderson Cancer Center in Google Maps
Recruiting
One Study Center