A Phase 2/3 interventional study of Prucalopride and Placebo in Gastroparesis and Diabetes Mellitus, sponsored by University of Calgary. Completed at 1 site in Canada. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by University of Calgary · Phase 2/3, Interventional, and Treatment
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:
307 studies on the registry are indexed under Gastroparesis; 68 are open to participants now.
This study's enrollment of 15 is below the median of 44 across 202 interventional studies indexed under Gastroparesis.
Browse Gastroparesis studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A randomized assignment of prucalopride or placebo for a period of 28 days, crossover design
Drug: Prucalopride · Drug: Placebo
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.
Drug: Prucalopride · Drug: Placebo
2 X 2 mg tablets (encapsulated) by mouth once daily for 28 days
Also known as: Resotran
2 X 100mg tablets (encapsulated) by mouth once daily for 28 days
Also known as: Lactose Monohydrate
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.
Time frame: Pre-intervention and on Day 28 for each of the two treatment periods
Gastric Emptying Rate
Percent remaining at 1, 2 and 4 hours will be determined from data gathered during 4 hour scintigraphic gastric emptying test
Time frame: On Day 28 for each of the two treatment phases
Plan to share: No
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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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University of Calgary