Treatment of Dysphagia and Ineffective Esophageal Motility With Prucalopride: A Pilot Study

• Status: Completed
• Trial end date: 2019-12-02
• Target enrollment: 0
• Participant gender: All

Summary

This study will test prucalopride (a prokinetic drug currently approved by Health Canada for treatment of constipation) as a treatment for Ineffective Esophageal Motility (IEM). Adult patients with previously diagnosed IEM will be invited to participate by the investigators. The participants will take the study medication for 5 days and on the final day of medication undergo an esophageal manometry procedure at the Calgary Gut Motility Centre to measure esophageal function. Symptoms and side effects will be tracked at baseline and on Day 5.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Treatments: Prucalopride

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