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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1775 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-07-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Chronic Constipation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Prucalopride

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No