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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03244553
Recruitment Status : Enrolling by invitation
First Posted : August 9, 2017
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Michelle Buresi, University of Calgary

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.

Condition or disease Intervention/treatment Phase
Ineffective Esophageal Motility Dysphagia Drug: Prucalopride Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Dysphagia and Ineffective Esophageal Motility With Prucalopride: A Pilot Study
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active intervention
Prucalopride for 5 days. Dosage: day 1 2mg, days 3-5 4mg
Drug: Prucalopride
5 day treatment




Primary Outcome Measures :
  1. Change in number of successful swallows [ Time Frame: Baseline and on day 5 of treatment ]
    Esophageal Manometry


Secondary Outcome Measures :
  1. Change in Dysphagia Questionnaire Score [ Time Frame: Baseline and on day 5 of treatment ]
    Mayo 30

  2. Change in EQ-5D Score [ Time Frame: Baseline and on day 5 of treatment ]
    Quality of life/health related



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244553


Locations
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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Michelle Buresi, MD, PhD University of Calgary

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Responsible Party: Michelle Buresi, Principal Investigator, University of Calgary
ClinicalTrials.gov Identifier: NCT03244553     History of Changes
Other Study ID Numbers: CGMC-Pru-02
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Prucalopride
Laxatives
Gastrointestinal Agents
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs