Study to Evaluate Long-Term Safety, Tolerability, and Satisfaction With Prucalopride in Chronic Constipation

Movetis

Status and phase: Completed; Phase 3

Conditions: Chronic Constipation

Treatments: Drug: Prucalopride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00987844

PRU-USA-22

Details and patient eligibility

About

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).

Enrollment: 1,775 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age.
2. 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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)