Status:
COMPLETED
Treatment of Dysphagia and Ineffective Esophageal Motility With Prucalopride: A Pilot Study
Lead Sponsor:
University of Calgary
Conditions:
Ineffective Esophageal Motility
Dysphagia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 pr...
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 hist...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03244553
Start Date
October 20 2017
End Date
December 2 2019
Last Update
March 25 2020
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 1N4