Ineffective Esophageal MotilityPhase 2IEMPruNCT03244553
Treatment of Dysphagia and Ineffective Esophageal Motility With Prucalopride: A Pilot Study
A Phase 2 study testing Prucalopride in people with Ineffective Esophageal Motility and Dysphagia, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ineffective Esophageal Motility, Dysphagia
- What is being tested?
- Prucalopride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 20 Oct 2017to 2 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Ineffective Esophageal Motility, Dysphagia
- Being tested
- Prucalopride
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrucaloprideDrug
5 day treatment
| Study group | Role | What they receive |
|---|---|---|
| Active intervention | Experimental | Prucalopride for 5 days. Dosage: day 1 2mg, days 3-5 4mg Receives: Drug: Prucalopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of successful swallows
Esophageal Manometry
Measured: Baseline and on day 5 of treatment
Secondary outcomes (2)
Change in Dysphagia Questionnaire Score
Mayo 30
Measured: Baseline and on day 5 of treatment
Change in EQ-5D Score
Quality of life/health related
Measured: Baseline and on day 5 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start20 Oct 2017
- Primary completion2 Dec 2019
- Study completion2 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ineffective Esophageal MotilityStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Buresi, University of Calgary
- Investigators
- Michelle Buresi, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244553
- Sponsor's protocol ID
- CGMC-Pru-02
- Acronym
- IEMPru
- Status last verified
- Mar 2020
- First submitted
- 1 Aug 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Dysphagia and Ineffective Esophageal Motility With Prucalopride: A Pilot Study
- ClinicalTrials.gov ID
- NCT03244553
- Acronym / sponsor ID
- IEMPru / CGMC-Pru-02
- Conditions
- Ineffective Esophageal Motility, Dysphagia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active intervention | Experimental | Drug: PrucalopridePrucalopride for 5 days. Dosage: day 1 2mg, days 3-5 4mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prucalopride5 day treatment | Drug | Active intervention |
Primary outcome
Change in number of successful swallows
Time frame: Baseline and on day 5 of treatment
Esophageal Manometry
2 secondary outcomes
Change in Dysphagia Questionnaire Score
Time frame: Baseline and on day 5 of treatment
Change in EQ-5D Score
Time frame: Baseline and on day 5 of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Ineffective Esophageal Motility
Recruiting
Evolution of the Chicago Classification: Bridging Physiology and Mechanics
Dysphagia, Achalasia, Esophageal
Recruiting
High Resolution Manometry After Partial Fundoplication for Gastro-oesophageal Reflux
Gastroesophageal Reflux, Esophageal Motility Disorders
Recruiting
The Influence of Specialized Food Products Based on Ice-Cream on Esophageal Motility
Ineffective Esophageal Motility, GERD (Gastroesophageal Reflux Disease)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Buresi, MD, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prucalopride in people with Ineffective Esophageal Motility and Dysphagia, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of successful swallows (time frame: Baseline and on day 5 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.