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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Movetis
• Treatments: Prucalopride

Criteria

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.