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

This study has been completed.
Sponsor:
Information provided by:
Movetis
ClinicalTrials.gov Identifier:
NCT01070615
First received: February 17, 2010
Last updated: March 1, 2010
Last verified: February 2010
  Purpose

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)
  Eligibility

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

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
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: NCT01070615

Locations
Belgium
University Hospital Antwerp
Edegem, Belgium, 2650
Sponsors and Collaborators
Movetis
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Renate Specht Gryp, Movetis
ClinicalTrials.gov 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:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014