Clinical trial: Treatment of Dysphagia and Ineffective Esophageal Motility With Prucalopride: A Pilot Study (NCT03244553)

Eligibility criteria:
Inclusion Criteria:

          -  Symptom of dysphagia

          -  Esophageal findings consistent with ineffective esophageal motility (IEM), defined as
             per the Chicago Classification as ≥50% ineffective swallows. Ineffective swallows
             include both failed swallows, defined by an average distal contractile integral (DCI)
             <100mmHg*cm*sec, and weak swallows, defined by an average DCI >100 but <450mmHg*cm*sec

          -  Normal endoscopy

          -  If female of childbearing potential, a negative urine pregnancy test administered 1
             day prior to taking the study medication (prucalopride)

          -  Able to provide informed consent

        Exclusion Criteria:

          -  Clinical evidence (on history, physical exam, or investigations) of significant
             cardiovascular, respiratory, gastrointestinal, hepatic, hematological, renal,
             neurological, or psychiatric comorbidities that may interfere with the objectives of
             the study and/or pose safety concerns, including pregnancy and breastfeeding

          -  History of cardiovascular disorder including myocardial infarction, life-threatening
             arrhythmias, pacemaker or defibrillator

          -  Estimated GFR <30, documented within 6 months preceding study entry

          -  Blood electrolytes (Na, K, CL) measured within past 6 months outside of normal
             reference ranges

          -  Uncontrolled gastroesophageal reflux disease on pH testing (DeMeester score >14.7)

          -  Established esophageal motility disorder, including but not limited to achalasia,
             spastic disorders, Esophagogastric junction (EGJ) outflow obstruction, and absent
             contractility

          -  History of gastrointestinal surgery, including hiatal hernia repair and/or
             fundoplication, or any major surgery in the 3 months preceding study entry

          -  Use of narcotics or prokinetic treatments that cannot be stopped prior to study entry

          -  Use of laxatives that cannot be stopped prior to study entry

          -  Use of tricyclic antidepressants at a dose of >25 mg daily (stable doses of SSRIs/
             SNRIs are permitted)

          -  Use of macrolide antibiotics (non-macrolide antibiotics are permitted)

          -  Participation in clinical trial with prokinetic treatment in the 30 days preceding
             study entry
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough.  Her other medical problems include hypertension, dyslipidemia, and osteoarthritis.  She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg.  The patient's breath smells bad. Other physical examinations are normal.  A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus.

Patient description (patient's own words): I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus.

Does the patient match the trial criteria? Contradiction