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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 17, 2010

Last Updated Date

March 1, 2010

Start Date ^ICMJE

June 1998

Primary Completion Date

November 2000 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01070615 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Study to Evaluate the Long-Term Tolerability and Safety of Oral Prucalopride Administered to Patients With Chronic Constipation

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Constipation

Intervention ^ICMJE

Drug: Prucalopride

Study Arm (s)

Not Provided

Publications *

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. Epub 2010 Sep 16.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

693

Completion Date

Not Provided

Primary Completion Date

November 2000 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Patients with impaired renal function
Patients with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
Females of child-bearing potential without adequate contraceptive protection during the study.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01070615

Other Study ID Numbers ^ICMJE

PRU-INT-10

Has Data Monitoring Committee

Responsible Party

Renate Specht Gryp, Movetis

Study Sponsor ^ICMJE

Movetis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Marc Van Outryve, MD

University Hospital Antwerp, Edegem, Belgium

Information Provided By

Movetis

Verification Date

February 2010

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

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