Domperidone in Treating Patients With Gastrointestinal Disorders

NCT01696734 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: 2012-0261NCI-2012-02093
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This phase III trial studies how well domperidone works in treating patients with gastrointestinal disorders. Domperidone may help control chronic gastrointestinal disorders and their symptoms, such as pain, bloating, and nausea and vomiting, by stimulating contraction of the stomach to increase its ability to empty itself of food.

Conditions

Digestive System Disorder; Esophagitis; Gastroesophageal Reflux Disease; Gastroparesis; Nausea and Vomiting; Dyspepsia; Heartburn

Outcome Measures

Primary Outcomes (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.

  Baseline to 8 weeks

Secondary Outcomes (2)

• Change in patients' self-report of symptoms

  Baseline to 30 days after completion of study treatment

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

  Up to 30 days after completion of study treatment

Study Arms (1)

Treatment (domperidone)

EXPERIMENTAL

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

Drug: Domperidone; Other: Questionnaire Administration

Interventions

Domperidone DRUG

Given PO

Also known as: KW 5338, Motilium, R 33,812

Treatment (domperidone)

Questionnaire Administration OTHER

Ancillary studies

Treatment (domperidone)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Digestive System Diseases; Dyspepsia; Esophagitis; Gastroesophageal Reflux; Gastroparesis; Heartburn; Nausea; Vomiting

Interventions

Domperidone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Gastroenteritis; Esophageal Motility Disorders; Deglutition Disorders; Stomach Diseases; Paralysis; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mehnaz Shafi

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehnaz Shafi

CONTACT

713-794-5073; mashafi@mdanderson.orgs

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 1, 2012
• Study Start: October 23, 2012
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)