Status:
COMPLETED
Study to Evaluate Long-Term Safety, Tolerability, and Satisfaction With Prucalopride in Chronic Constipation
Lead Sponsor:
Movetis
Conditions:
Chronic Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1775 Patients enrolled
Trial Details
Trial ID
NCT00987844
Start Date
July 1 1998
Last Update
October 1 2009
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905