Study to Evaluate Long-Term Safety, Tolerability, and Satisfaction With Prucalopride in Chronic Constipation

A Study to Evaluate the Long-Term Tolerability, Safety, Patient Satisfaction, Pharmacokinetics, and Use Patterns of Oral Prucalopride Tablets in Patients With Chronic Constipation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00987844

Enrollment

1775

Registered

2009-10-01

Start date

1998-07-31

Completion date

Unknown

Last updated

2009-10-01

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: To evaluate the clinical long-term safety and the tolerability, patient satisfaction, pharmacokinetics and use of pattern of prucalopride given in doses up to 4 mg per day to patients with chronic constipation (CC).

Interventions

DRUGPrucalopride

1 mg tablets, free dosing regiment with max. of 4 tablets o.d., treatment duration: up to 24 months

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 and non-pregnant, non breast-feeding female outpatients at least 18 years of age. 2. Patient completed the entire treatment period of one of the following studies: PRU-USA-3, PRU-USA-11, PRU-USA-13, PRU-USA-21, PRU-USA-25, PRU-USA-27 or PRU-USA-28, or Patient participated in the re-treatment study PRU-USA-28 and did not qualify for Treatment period II after both washout periods.

Exclusion criteria

1. Patient with impaired renal function 2. Patient with clinically significant abnormalities of haematology, urinalysis, or blood chemistry. 3. Female of childbearing potential without adequate contraceptive protection during the study. 4. Patient who used an investigation drug other than prucalopride in the 30 days preceding the study.

Design outcomes

Primary

Measure	Time frame
Safety: adverse events, lab tests, vital signs, ECGs	24 months

Secondary

Measure	Time frame
Efficacy: PAC-QOL self-administered questionnaire, Patient's pattern of use of prucalopride	24 months
Pharmacokinetics: Prucalopride plasmaconcentrations	24 months

Countries

United States

Outcome results

None listed

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