Prucalopride Versus Placebo in Diabetic Gastroparesis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Calgary
Sponsor:
Collaborator:
Janssen Inc.
Information provided by (Responsible Party):
Christopher Andrews, University of Calgary
ClinicalTrials.gov Identifier:
NCT02031081
First received: January 5, 2014
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

The incidence of gastroparesis has been increasing among Canadians who have either Type 1 or Type 2 Diabetes. 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. 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 both diabetes and 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 diabetic 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.

Condition Intervention Phase
Gastroparesis
Diabetes Mellitus
Drug: Prucalopride
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Prucalopride Versus Placebo in Diabetic Gastroparesis: Randomized Placebo-controlled Crossover Trial

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Change In Cumulative Meal-related Symptoms [ Time Frame: Pre-intervention and on Day 28 for each of the two treatment periods ] [ Designated as safety issue: No ]
    Self assessment of 6 gastric related symptoms using a scale of 0-3 measured before and every 15 minutes during scintigraphic gastric emptying test.


Secondary Outcome Measures:
  • Gastric Emptying Rate [ Time Frame: On Day 28 for each of the two treatment phases ] [ Designated as safety issue: No ]
    Percent remaining at 1, 2 and 4 hours will be determined from data gathered during 4 hour scintigraphic gastric emptying test


Estimated Enrollment: 30
Study Start Date: March 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Period 1
A randomized assignment of prucalopride or placebo for a period of 28 days, crossover design
Drug: Prucalopride
2 X 2 mg tablets (encapsulated) by mouth once daily for 28 days
Other Name: Resotran
Drug: Placebo
2 X 100mg tablets (encapsulated) by mouth once daily for 28 days
Other Name: Lactose Monohydrate
Experimental: Treatment Period 2
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
2 X 2 mg tablets (encapsulated) by mouth once daily for 28 days
Other Name: Resotran
Drug: Placebo
2 X 100mg tablets (encapsulated) by mouth once daily for 28 days
Other Name: Lactose Monohydrate

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 18-64 years
  • Existing clinical diagnosis of diabetes (Type 1 or 2) and 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

Exclusion Criteria:

  • 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 7
  • 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 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02031081

Contacts
Contact: Lynn H Wilsack, MSc 403 592-5045 lwilsack@ucalgary.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Principal Investigator: Christopher N Andrews, MD, MSc         
Sub-Investigator: Michael Curley, MD         
Sub-Investigator: Michelle Buresi, MD         
Sub-Investigator: Milli Gupta, MD         
Sponsors and Collaborators
University of Calgary
Janssen Inc.
Investigators
Principal Investigator: Christopher N Andrews, MD, MSc University of Calgary
  More Information

No publications provided

Responsible Party: Christopher Andrews, Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02031081     History of Changes
Other Study ID Numbers: PruGP
Study First Received: January 5, 2014
Last Updated: March 7, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Gastroparesis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014