Study to Evaluate Long-Term Safety, Tolerability, and Satisfaction With Prucalopride in Chronic Constipation
Phase 3
Completed
- Conditions
- Chronic Constipation
- Registration Number
- NCT00987844
- Lead Sponsor
- Movetis
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1775
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety: adverse events, lab tests, vital signs, ECGs 24 months
- Secondary Outcome Measures
Name Time Method Efficacy: PAC-QOL self-administered questionnaire, Patient's pattern of use of prucalopride 24 months Pharmacokinetics: Prucalopride plasmaconcentrations 24 months
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States