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

Movetis

Status and phase: Completed; Phase 3

Conditions: Chronic Constipation

Treatments: Drug: Prucalopride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01070615

PRU-INT-10

Details and patient eligibility

About

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

Enrollment: 693 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)