Diabetes Mellitus Clinical Trial
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
In patients with gastroparesis:
1. Prucalopride 4 mg daily improves meal-related symptoms compared to placebo as defined by
the change in cumulative meal-related symptoms. (primary endpoint).
2. Prucalopride 4 mg daily accelerates gastric emptying rate compared to placebo.
(secondary endpoint).
3. A correlation exists between the effect of prucalopride on gastric emptying rate and
symptom improvement.
n/a
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