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

Movetis693 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

693

Conditions

Chronic Constipation

Interventions

PrucaloprideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital Antwerp

Edegem, Belgium

Data from ClinicalTrials.gov

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