Domperidone in Treating Patients With Gastrointestinal Disorders

Treatment Protocol for the Compassionate Use of Domperidone

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.

Study Overview

• Status: Recruiting
• Conditions: Dyspepsia; Esophagitis; Gastroesophageal Reflux Disease; Gastroparesis; Heartburn; Nausea and Vomiting; Digestive System Disorder
• Intervention / Treatment: Other: Questionnaire Administration; Drug: Domperidone

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mehnaz Shafi; Phone Number: 713-794-5073; Email: mashafi@mdanderson.orgs

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Principal Investigator: Mehnaz Shafi
      • Contact: Mehnaz Shafi; Phone Number: 713-794-5073

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (domperidone); Patients receive domperidone PO TID or QID. Treatment continues in the absence of disease progression or unacceptable toxicity.	Other: Questionnaire Administration; Ancillary studies; Drug: Domperidone; Given PO; Other Names: Motilium; KW 5338; R 33,812

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	Up to 30 days after completion of study treatment

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Mehnaz Shafi, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2012
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: September 27, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimated): October 1, 2012

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Signs and Symptoms, Digestive; Stomach Diseases; Gastroenteritis; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Paralysis; Dyspepsia; Vomiting; Gastroesophageal Reflux; Gastrointestinal Diseases; Digestive System Diseases; Gastroparesis; Heartburn; Esophagitis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine Antagonists; Domperidone
• Other Study ID Numbers: 2012-0261 (Other Identifier: M D Anderson Cancer Center); NCI-2012-02093 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No