Back to resultsStudy to Evaluate Long-Term Tolerability and Safety of Oral Prucalopride in Chronic Constipation
Primary Purpose
Chronic Constipation
Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Prucalopride
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Constipation
Eligibility Criteria
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.
Sites / Locations
- University Hospital Antwerp
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01070615
Brief Title
Study to Evaluate Long-Term Tolerability and Safety of Oral Prucalopride in Chronic Constipation
Official Title
A Study to Evaluate the Long-Term Tolerability and Safety of Oral Prucalopride Administered to Patients With Chronic Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
November 2000 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Movetis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
693 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Prucalopride
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Van Outryve, MD
Organizational Affiliation
University Hospital Antwerp, Edegem, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Antwerp
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
21039673
Citation
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.
Results Reference
derived
Learn more about this trial
Study to Evaluate Long-Term Tolerability and Safety of Oral Prucalopride in Chronic Constipation
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