A Study to Evaluate the Long-Term Tolerability, Safety, Patient Satisfaction, Pharmacokinetics, and Use Patterns of Oral Prucalopride Tablets in Patients With Chronic Constipation

Movetis1 site in 1 country1,775 target enrollmentJuly 1998

ConditionsChronic Constipation

DrugsPrucalopride

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Constipation
Sponsor: Movetis
Enrollment: 1775
Locations: 1
Primary Endpoint: Safety: adverse events, lab tests, vital signs, ECGs
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Objectives: To evaluate the clinical long-term safety and the tolerability, patient satisfaction, pharmacokinetics and use of pattern of prucalopride given in doses up to 4 mg per day to patients with chronic constipation (CC).

Registry

clinicaltrials.gov

Start Date

July 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 and non-pregnant, non breast-feeding female outpatients at least 18 years of age.
•Patient completed the entire treatment period of one of the following studies: PRU-USA-3, PRU-USA-11, PRU-USA-13, PRU-USA-21, PRU-USA-25, PRU-USA-27 or PRU-USA-28, or Patient participated in the re-treatment study PRU-USA-28 and did not qualify for Treatment period II after both washout periods.

Exclusion Criteria

•Patient with impaired renal function
•Patient with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
•Female of childbearing potential without adequate contraceptive protection during the study.
•Patient who used an investigation drug other than prucalopride in the 30 days preceding the study.

Outcomes

Primary Outcomes

Safety: adverse events, lab tests, vital signs, ECGs

Time Frame: 24 months

Secondary Outcomes

Efficacy: PAC-QOL self-administered questionnaire, Patient's pattern of use of prucalopride(24 months)
Pharmacokinetics: Prucalopride plasmaconcentrations(24 months)