Treatment of Dysphagia and Ineffective Esophageal Motility With Prucalopride: A Pilot Study (IEMPru)
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|ClinicalTrials.gov Identifier: NCT03244553|
Recruitment Status : Enrolling by invitation
First Posted : August 9, 2017
Last Update Posted : January 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ineffective Esophageal Motility Dysphagia||Drug: Prucalopride||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Active intervention
Prucalopride for 5 days. Dosage: day 1 2mg, days 3-5 4mg
5 day treatment
- Change in number of successful swallows [ Time Frame: Baseline and on day 5 of treatment ]Esophageal Manometry
- Change in Dysphagia Questionnaire Score [ Time Frame: Baseline and on day 5 of treatment ]Mayo 30
- Change in EQ-5D Score [ Time Frame: Baseline and on day 5 of treatment ]Quality of life/health related
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
|University of Calgary|
|Calgary, Alberta, Canada, T2N 1N4|
|Principal Investigator:||Michelle Buresi, MD, PhD||University of Calgary|