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Recruiting NCT01696734

Domperidone in Treating Patients With Gastrointestinal Disorders

Phase III Interventional Digestive System Disorder Dyspepsia Esophagitis Gastroesophageal Reflux Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Domperidone, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Digestive System Disorder, Dyspepsia, Esophagitis, Gastroesophageal Reflux Disease. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Treatment Protocol for the Compassionate Use of Domperidone

Overview

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.

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.

Interventions

  • Drug Domperidone
    Given PO
  • Other Questionnaire Administration
    Ancillary studies

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 [Time frame: Baseline to 8 weeks]
Secondary outcome measures (2)
  • Change in patients' self-report of symptoms [Time frame: 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 [Time frame: Up to 30 days after completion of study treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT01696734 · 2012-0261 · NCI-2012-02093 · 2012-0261

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗