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

A Study to Evaluate the Long-Term Tolerability and Safety of Oral Prucalopride Administered to Patients With Chronic Constipation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01070615

Enrollment

693

Registered

2010-02-18

Start date

1998-06-30

Completion date

Unknown

Last updated

2010-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Constipation

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

Interventions

DRUGPrucalopride

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026