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

Phase 3

Completed

• Conditions: Chronic Constipation

• Registration Number: NCT01070615
• Lead Sponsor: Movetis

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

Detailed Description

Not available

Study Timeline

• Study Start: 1998-06
• Primary Completion: 2000-11
• Status Verified: 2010-02
• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-18
• Last Update Submitted: 2010-03-01
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 693

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

University Hospital Antwerp; 🇧🇪 Edegem, Belgium