Treatment of Dysphagia and Ineffective Esophageal Motility With Prucalopride: A Pilot Study
Condition: Ineffective Esophageal Motility; Dysphagia
MeSH terms: Deglutition Disorders
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      As part of the standard clinical evaluation of our department, all patients presenting to the
      Calgary Gut Motility Centre with dysphagia routinely undergo a thorough clinical assessment
      including history taking and physical examination. Depending on their presentation, further
      evaluation may include upper endoscopy, barium swallow, esophageal manometry, and pH testing.

      Patients meeting inclusion and exclusion criteria will receive prucalopride for 5 days total,
      with 2mg on day 1, then 4mg on days 2 to 5. On day 5 of the intervention, patients will
      undergo esophageal manometry. Patients will also complete a symptoms questionnaire for
      assessment of dysphagia symptoms and the EQ-5D questionnaire for assessment of global quality
      of life at baseline and on day 5 of prucalopride treatment.

      Full research ethics approval will be obtained prior to commencement of the study.
      Participants will be recruited from patients completing esophageal manometry at the South
      Health Campus. Patients who have provided consent to be contacted for research studies and
      who have dysphagia and findings of ineffective esophageal motility (IEM) on manometry will be
      contacted by the study investigators. The results of their esophageal manometry will be
      reviewed with them, and the study will be described to them. If the patient is interested in
      study participation, then study investigators will arrange for the patient to come to the
      South Health Campus to review the study in detail prior to obtaining informed consent. Thirty
      patients will be enrolled in this study.

      Patients who meet all inclusion and exclusion criteria will be enrolled. Once enrolled, the
      participants will be asked to complete a symptom and quality of life questionnaire. They will
      receive the prucalopride pills, to be taken for 5 days with the following instructions: Day
      1, take 1 tablet (2 mg), on days 2 through 4, take 2 tablets (4mg) and on day 5, take 2
      tablets 1 hour prior to the second scheduled study appointment. On day 5, the patient will be
      scheduled at South Health Campus for esophageal manometry. Patients will also be asked to
      complete a post-treatment symptom and quality of life questionnaire at that time.
    

Intervention name(s): Prucalopride
Intervention type(s): Drug
Intervention description(s): 5 day treatment
Intervention MeSH terms: Prucalopride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment