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

Movetis1 site in 1 country693 target enrollmentJune 1998

ConditionsChronic Constipation

DrugsPrucalopride

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Constipation
Sponsor: Movetis
Enrollment: 693
Locations: 1
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 1998

End Date

November 2000

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Movetis

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.