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

NCT03244553 | Completed Phase 2

• 1 other identifier: CGMC-Pru-02
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Ineffective Esophageal Motility; Dysphagia

Outcome Measures

Primary Outcomes (1)

• Change in number of successful swallows

  Esophageal Manometry

  Baseline and on day 5 of treatment

Secondary Outcomes (2)

• Change in Dysphagia Questionnaire Score

  Baseline and on day 5 of treatment

• Change in EQ-5D Score

  Baseline and on day 5 of treatment

Study Arms (1)

Active intervention

EXPERIMENTAL

Prucalopride for 5 days. Dosage: day 1 2mg, days 3-5 4mg

Drug: Prucalopride

Interventions

Prucalopride DRUG

5 day treatment

Active intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

prucalopride

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Michelle Buresi, MD, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 9, 2017
• Study Start: October 20, 2017
• Primary Completion: December 2, 2019
• Study Completion: December 2, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)