Prucalopride Versus Placebo in Gastroparesis

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. 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.

Conditions

• Gastroparesis
• Diabetes Mellitus

Interventions

DRUG

Prucalopride

2 X 2 mg tablets (encapsulated) by mouth once daily for 28 days

DRUG

Placebo

2 X 100mg tablets (encapsulated) by mouth once daily for 28 days

Sponsors & Collaborators

• Janssen Inc.

  collaborator INDUSTRY

• University of Calgary

  lead OTHER

Principal Investigators

• Christopher N Andrews, MD, MSc · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2018-06-30

Completion

2018-06-30

Countries

• Canada

Study Locations