Study to Evaluate Long-Term Tolerability and Safety of Oral Prucalopride in Chronic Constipation

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

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

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

Details

• Lead Sponsor: Movetis
• Treatments: Prucalopride

Criteria

Inclusion Criteria:

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

2. Patient had completed the entire treatment period of the PRU-INT-6 study or the PRU-INT-12 study .

Exclusion Criteria:

1. Patients with impaired renal function

2. Patients with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.

3. Females of child-bearing potential without adequate contraceptive protection during the study.