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

Completed · Phase 3

Conditions studied: Chronic Constipation

In brief

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).

Key facts

Study ID

NCT00987844

Run by

Movetis

People needed

1775

Starts

1998-07-01

Last updated by the study team

2009-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age.
• 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.

You may not qualify if…

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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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