GastroparesisPhase 2/3NCT02031081
Prucalopride Versus Placebo in Gastroparesis
A Phase 2/3 study testing Prucalopride in people with Gastroparesis and Diabetes Mellitus, run by University of Calgary at 1 site in Canada.
Trial summary
The incidence of gastroparesis has been increasing among Canadians. Symptoms of discomfort include early satiety, stomach pain, nausea and vomiting. In addition, because gastroparesis slows digestion, it can lead to malnutrition and make controlling blood sugar even more challenging for diabetics. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Gastroparesis, Diabetes Mellitus
- What is being tested?
- Prucalopride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Jun 2018
- Phase
- Phase 2/3
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age of 18-64 years
- Existing clinical diagnosis of gastroparesis for at least one year as judged by the study gastroenterologist based on past medical history, clinical symptoms
- Sufficiently symptomatic at time of proposed study (Minimum baseline postprandial satiety/fullness subscale of the Gastroparesis Cardinal Symptoms Index (GCSI) score of 1.5 or higher)
- Delayed gastric emptying (>10% retention at 4 hours) on standard solid meal scintigraphic emptying study within the previous year
- Normal upper endoscopy (with the exception of small bezoars) since the onset of symptoms
- If female of childbearing potential, a negative urine pregnancy test administered between consent and screening appointments
- Able to provide written informed consent
Who cannot join
- Clinical evidence (including physical exam and/or ECG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns, including pregnancy or breastfeeding.
- Study entry ECG showing second or third degree heart block, left bundle branch block (LBBB) or acute ischemic changes
- Blood electrolytes (Na, K, CL) measured within past 6 months outside of normal reference ranges (except during an acute gastroparesis flare-up)
- Use of narcotics or promotility agents which cannot be stopped prior to study entry.
- Use of tricyclic antidepressants (at doses exceeding 25 mg/day) and/or macrolide antibiotics. (Stable doses of SSRI/SNRI antidepressants and/or non-macrolide antibiotics are permitted)
- Laxative use that cannot be stopped prior to the start of the study
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- Participated in clinical trial with motility agents within past 30 days
- History of gastrointestinal surgery excepting appendectomy and/or cholecystectomy in the past, or any other major surgeries within 3 months
- Estimated GFR<30 measured within past 6 months.
- History of cardiovascular disorder including myocardial infarction, pacemaker or implanted defibrillator, or history of life-threatening arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prucalopride Versus Placebo in Gastroparesis: Randomized Placebo-controlled Crossover Trial
The incidence of gastroparesis has been increasing among Canadians. Symptoms of discomfort include early satiety, stomach pain, nausea and vomiting. In addition, because gastroparesis slows digestion, it can lead to malnutrition and make controlling blood sugar even more challenging for diabetics. Mild cases of gastroparesis can be helped with dietary and lifestyle modifications but treatments for more severe symptoms are limited. There are several drugs called pro-kinetics available in Canada though results vary among patients and these often cause significant side effects. Recently, a drug called Prucalopride was approved for use in Canada to treat constipation. It has pro-kinetic properties and has been shown to cause few side effects. The investigators propose to test prucalopride as a treatment for gastroparesis by recruiting 30 patients from the Calgary area who have gastroparesis. The investigators will test the effects of this treatment by alternating 28 days of active treatment with prucalopride with 28 days of treatment with a non active placebo adding a two week break in between treatments. The order of the treatment will be randomized and neither the patients nor the investigators will know whether they are receiving the active treatment or the placebo until the study has been completely finished. The investigators will measure the effects using questionnaires that assess patient symptoms such as nausea and pain as well as quality of life during two gastric emptying tests and throughout the treatment periods. The effectiveness of the active treatment will be evaluated by comparing the extent of the change in symptoms before and after treatments and the difference in gastric emptying times as compared to the placebo treatment. The investigators will also monitor and track all possible side effects that patients experience during the study.
Study Hypotheses
Read more
In patients with gastroparesis:
- Prucalopride 4 mg daily improves meal-related symptoms compared to placebo as defined by the change in cumulative meal-related symptoms. (primary endpoint).
- Prucalopride 4 mg daily accelerates gastric emptying rate compared to placebo. (secondary endpoint).
- A correlation exists between the effect of prucalopride on gastric emptying rate and symptom improvement.
- Conditions
- Gastroparesis, Diabetes Mellitus
- Being tested
- Prucalopride, Placebo
- Medical subject headings
- Gastroparesis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrucaloprideDrug
Also called Resotran
2 X 2 mg tablets (encapsulated) by mouth once daily for 28 days
PlaceboDrug
Also called Lactose Monohydrate
2 X 100mg tablets (encapsulated) by mouth once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment Period 1 | Experimental | A randomized assignment of prucalopride or placebo for a period of 28 days, crossover design Receives: Drug: Prucalopride; Drug: Placebo |
| Treatment Period 2 | Experimental | A randomized assignment of either prucalopride or placebo for a period of 28 days, crossover design. Subjects who received active drug in Treatment Arm 1 will receive placebo and vice versa. Receives: Drug: Prucalopride; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change In Cumulative Meal-related Symptoms
Self assessment of 6 gastric related symptoms using a scale of 0-3 measured before and every 15 minutes during scintigraphic gastric emptying test.
Measured: Pre-intervention and on Day 28 for each of the two treatment periods
Secondary outcomes (1)
Gastric Emptying Rate
Percent remaining at 1, 2 and 4 hours will be determined from data gathered during 4 hour scintigraphic gastric emptying test
Measured: On Day 28 for each of the two treatment phases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Inc.
- Responsible party
- Principal investigator, Christopher Andrews, University of Calgary
- Investigators
- Christopher N Andrews, MD, MSc, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031081
- Sponsor's protocol ID
- PruGP
- Status last verified
- Oct 2020
- First submitted
- 5 Jan 2014
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prucalopride Versus Placebo in Gastroparesis: Randomized Placebo-controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT02031081
- Acronym / sponsor ID
- PruGP
- Conditions
- Gastroparesis, Diabetes Mellitus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Janssen Inc.
- Study start
- Mar 2014
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 9 Jan 2014 (estimated)
- 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.
The incidence of gastroparesis has been increasing among Canadians. Symptoms of discomfort include early satiety, stomach pain, nausea and vomiting. In addition, because gastroparesis slows digestion, it can lead to malnutrition and make controlling blood sugar even more challenging for diabetics. Mild cases of gastroparesis can be helped with dietary and lifestyle modifications but treatments for more severe symptoms are limited. There are several drugs called pro-kinetics available in Canada though results vary among patients and these often cause significant side effects. Recently, a drug called Prucalopride was approved for use in Canada to treat constipation. It has pro-kinetic properties and has been shown to cause few side effects. The investigators propose to test prucalopride as a treatment for gastroparesis by recruiting 30 patients from the Calgary area who have gastroparesis. The investigators will test the effects of this treatment by alternating 28 days of active treatment with prucalopride with 28 days of treatment with a non active placebo adding a two week break in between treatments. The order of the treatment will be randomized and neither the patients nor the investigators will know whether they are receiving the active treatment or the placebo until the study has been completely finished. The investigators will measure the effects using questionnaires that assess patient symptoms such as nausea and pain as well as quality of life during two gastric emptying tests and throughout the treatment periods. The effectiveness of the active treatment will be evaluated by comparing the extent of the change in symptoms before and after treatments and the difference in gastric emptying times as compared to the placebo treatment. The investigators will also monitor and track all possible side effects that patients experience during the study.
Study Hypotheses
In patients with gastroparesis:
- Prucalopride 4 mg daily improves meal-related symptoms compared to placebo as defined by the change in cumulative meal-related symptoms. (primary endpoint).
- Prucalopride 4 mg daily accelerates gastric emptying rate compared to placebo. (secondary endpoint).
- A correlation exists between the effect of prucalopride on gastric emptying rate and symptom improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Period 1 | Experimental | Drug: Prucalopride, Drug: PlaceboA randomized assignment of prucalopride or placebo for a period of 28 days, crossover design |
| Treatment Period 2 | Experimental | Drug: Prucalopride, Drug: PlaceboA randomized assignment of either prucalopride or placebo for a period of 28 days, crossover design. Subjects who received active drug in Treatment Arm 1 will receive placebo and vice versa. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age of 18-64 years
- Existing clinical diagnosis of gastroparesis for at least one year as judged by the study gastroenterologist based on past medical history, clinical symptoms
- Sufficiently symptomatic at time of proposed study (Minimum baseline postprandial satiety/fullness subscale of the Gastroparesis Cardinal Symptoms Index (GCSI) score of 1.5 or higher)
- Delayed gastric emptying (>10% retention at 4 hours) on standard solid meal scintigraphic emptying study within the previous year
- Normal upper endoscopy (with the exception of small bezoars) since the onset of symptoms
Key exclusion criteria (10 listed)
- Clinical evidence (including physical exam and/or ECG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns, including pregnancy or breastfeeding.
- Study entry ECG showing second or third degree heart block, left bundle branch block (LBBB) or acute ischemic changes
- Blood electrolytes (Na, K, CL) measured within past 6 months outside of normal reference ranges (except during an acute gastroparesis flare-up)
- Use of narcotics or promotility agents which cannot be stopped prior to study entry.
- Use of tricyclic antidepressants (at doses exceeding 25 mg/day) and/or macrolide antibiotics. (Stable doses of SSRI/SNRI antidepressants and/or non-macrolide antibiotics are permitted)
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 |
|---|---|---|
| PrucaloprideAlso: Resotran2 X 2 mg tablets (encapsulated) by mouth once daily for 28 days | Drug | Treatment Period 1, Treatment Period 2 |
| PlaceboAlso: Lactose Monohydrate2 X 100mg tablets (encapsulated) by mouth once daily for 28 days | Drug | Treatment Period 1, Treatment Period 2 |
Primary outcome
Change In Cumulative Meal-related Symptoms
Time frame: Pre-intervention and on Day 28 for each of the two treatment periods
Self assessment of 6 gastric related symptoms using a scale of 0-3 measured before and every 15 minutes during scintigraphic gastric emptying test.
1 secondary outcome
Gastric Emptying Rate
Time frame: On Day 28 for each of the two treatment phases
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 8 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Christopher N Andrews, MD, MSc 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 2/3 study testing Prucalopride in people with Gastroparesis and Diabetes Mellitus, 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 7 inclusion and 10 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 8 Oct 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Cumulative Meal-related Symptoms (time frame: Pre-intervention and on Day 28 for each of the two treatment periods). 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 8 Oct 2020.