Domperidone in Treating Patients With Gastrointestinal Disorders

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by M.D. Anderson Cancer Center
Sponsor
M.D. Anderson Cancer Center
Information Provided by (Responsible Party)
M.D. Anderson Cancer Center
Clinicaltrials.gov Identifier
NCT01696734
Other Study ID Numbers:
2012-0261
First Submitted
September 26, 2012
First Posted
September 30, 2012
Last Update Posted
April 12, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

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.

Condition or DiseaseIntervention/Treatment
Digestive System DisorderDyspepsiaEsophagitisGastroesophageal Reflux DiseaseGastroparesisHeartburnNausea and Vomiting
Drug: Domperidone

Study Design

Study TypeInterventional
Actual Enrollment200 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeOther
Official TitleTreatment Protocol for the Compassionate Use of Domperidone
Study Start DateOctober 22, 2012
Actual Primary Completion Date1yr 1mo from now
Actual Study Completion Date1yr 1mo from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Treatment (domperidone)
Patients receive domperidone PO TID or QID. Treatment continues in the absence of disease progression or unacceptable toxicity.
Drug: Domperidone
Given PO

Outcome Measures

Primary Outcome Measures
  1. Attenuation of symptoms associated with disorder(s) of gastrointestinal motility, measured by change in Gastroparesis Cardinal Symptom Index (GSCI) score from baseline
    Scale ranges from "0" meaning "None" to "5" meaning "Very Severe". Patients will be classified as either "new" or "continuing" at the baseline visit. A new patient will have a "response" if he/she has a 25% reduction in GCSI at 8 weeks. A continuing patient will already have early benefit to treatment so will have a "response" if the GCSI score does not increase more than 20% over baseline at 8 weeks. Summary statistics including number (n), mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed.
Secondary Outcome Measures
  1. Change in patients' self-report of symptoms
    Summary statistics including n, mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed.
  2. Incidence of toxicities assessed according to the Common Terminology Criteria for Adverse Events version 4.0
    Summary statistics including n, mean, standard deviation, median, minimum, and maximum will be computed. Bayesian 95% credible intervals will be computed. Patient adverse events will be tabulated by symptom, grade, and relationship to study drug.

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Patients with GI disorders who have failed standard therapy
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
Completion of a comprehensive evaluation, including clinical history and physical examination, to eliminate other causes of their symptoms
Patient has signed the informed consent document agreeing to the use of the study drug, domperidone
White blood cell (WBC) with differential greater than 3,000/ml
Alkaline phosphatase less than 1.5 x upper limit of normal
Alanine aminotransferase (ALT) less than 2 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
Blood urea nitrogen (BUN) less than 2 x upper limit of normal
Creatinine less than 1.5 x upper limit of normal
Stable hemoglobin greater than or equal to 8.0 g/dl
Potassium between range of 3.0 to 5.5
Magnesium level between 1.6-2.6 mg
Exclusion Criteria
Patients with the following cardiac diagnoses: ventricular tachycardia or fibrillation; Torsade des Pointes; clinically significant bradycardia; sinus node dysfunction; heart block; prolonged QTc interval (QTc \> 450 milliseconds for males, QTc \> 470 milliseconds for females); prior specific cardiovascular conditions of clinically significant valvular heart disease requiring medication, ischemic, or pulmonary heart disease; cardiomyopathy; history of heart failure
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 who are receiving monoamine oxidase (MAO) inhibitors
Patients with a history of or active liver failure
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
Presence of a prolactinoma (prolactin-releasing pituitary tumor)
Pregnant or breast-feeding female (women of childbearing potential \[WOCBP\], defined as not post-menopausal for 12 months or without previous surgical sterilization, must have a negative urine pregnancy test within 30 days of the first administration of domperidone and must either commit to continued abstinence from heterosexual intercourse or use an effective method of birth control during the course of the study)
Known allergy to domperidone

Contacts and Locations

Sponsors and CollaboratorsM.D. Anderson Cancer Center
Locations
M D Anderson Cancer Center | Houston Texas, United States, 77030
Investigators
Principal Investigator: Mehnaz Shafi, M.D. Anderson Cancer Center