Study to Evaluate Long-Term Safety, Tolerability, and Satisfaction With Prucalopride in Chronic Constipation
NCT00987844 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1775
Last updated 2009-10-01
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).
Conditions
- Chronic Constipation
Interventions
- DRUG
-
Prucalopride
1 mg tablets, free dosing regiment with max. of 4 tablets o.d., treatment duration: up to 24 months
Sponsors & Collaborators
-
Movetis
lead INDUSTRY
Principal Investigators
-
Michael Camilleri, MD · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1998-07-31
- Primary Completion
- 2000-11-30
Countries
- United States
Study Locations
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