Study to Evaluate Long-Term Tolerability and Safety of Oral Prucalopride in Chronic Constipation

This study has been completed.
Information provided by:
Movetis Identifier:
First received: February 17, 2010
Last updated: March 1, 2010
Last verified: February 2010

Objectives: Evaluation of the clinical long-term safety, tolerability, patient satisfaction, pharmacokinetics and pattern of use of oral prucalopride tablets given in doses up to 4 mg once daily to patients with chronic constipation

Condition Intervention Phase
Chronic Constipation
Drug: Prucalopride
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Long-Term Tolerability and Safety of Oral Prucalopride Administered to Patients With Chronic Constipation

Resource links provided by NLM:

Further study details as provided by Movetis:

Enrollment: 693
Study Start Date: June 1998
Primary Completion Date: November 2000 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or non-pregnant, non-breast-feeding female outpatients of at least 18 years of age
  2. Patient had completed the entire treatment period of the PRU-INT-6 study or the PRU-INT-12 study .

Exclusion Criteria:

  1. Patients with impaired renal function
  2. Patients with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
  3. Females of child-bearing potential without adequate contraceptive protection during the study.
  Contacts and Locations
Please refer to this study by its identifier: NCT01070615

University Hospital Antwerp
Edegem, Belgium, 2650
Sponsors and Collaborators
Principal Investigator: Marc Van Outryve, MD University Hospital Antwerp, Edegem, Belgium
  More Information

No publications provided by Movetis

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Renate Specht Gryp, Movetis Identifier: NCT01070615     History of Changes
Other Study ID Numbers: PRU-INT-10
Study First Received: February 17, 2010
Last Updated: March 1, 2010
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on April 15, 2014