Clinical trial NCT01696734: Domperidone in Treating Patients With Gastrointestinal Disorders
Official title: Treatment Protocol for the Compassionate Use of Domperidone
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Digestive System Disorder
Dyspepsia
Esophagitis
Gastroesophageal Reflux Disease
Gastroparesis
Heartburn
Nausea and Vomiting
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-10-01
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Attenuation of symptoms associated with disorder(s) of gastrointestinal motility, measured by change in Gastroparesis Cardinal Symptom Index (GSCI) score from baseline
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Change in patients' self-report of symptoms
timeFrame: Baseline to 30 days after completion of study treatment
measure: Incidence of toxicities assessed according to the Common Terminology Criteria for Adverse Events version 4.0
timeFrame: Up to 30 days after completion of study treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Mehnaz Shafi
role: PRINCIPAL_INVESTIGATOR
References: