Clinical trial: Domperidone in Treating Patients With Gastrointestinal Disorders (NCT01696734)

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; Torsades de pointes; clinically significant bradycardia; sinus node
             dysfunction; heart block; prolonged corrected QT (QTc) interval (QTc > 450
             milliseconds for males, QTc > 470 milliseconds for females); valvular, 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.


Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? Entailment