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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01070615
First Posted: February 18, 2010
Last Update Posted: March 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Movetis
February 17, 2010
February 18, 2010
March 2, 2010
June 1998
November 2000   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01070615 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study to Evaluate Long-Term Tolerability and Safety of Oral Prucalopride in Chronic Constipation
A Study to Evaluate the Long-Term Tolerability and Safety of Oral Prucalopride Administered to Patients With Chronic Constipation
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
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Constipation
Drug: Prucalopride
Not Provided
Camilleri M, Van Outryve MJ, Beyens G, Kerstens R, Robinson P, Vandeplassche L. Clinical trial: the efficacy of open-label prucalopride treatment in patients with chronic constipation - follow-up of patients from the pivotal studies. Aliment Pharmacol Ther. 2010 Nov;32(9):1113-23. doi: 10.1111/j.1365-2036.2010.04455.x. Epub 2010 Sep 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
693
Not Provided
November 2000   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01070615
PRU-INT-10
No
Not Provided
Not Provided
Renate Specht Gryp, Movetis
Movetis
Not Provided
Principal Investigator: Marc Van Outryve, MD University Hospital Antwerp, Edegem, Belgium
Movetis
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP