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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prucalopride | Drug | 1 mg tablets, free dosing regiment with max. of 4 tablets o.d., treatment duration: up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: adverse events, lab tests, vital signs, ECGs | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: PAC-QOL self-administered questionnaire, Patient's pattern of use of prucalopride | 24 months | |
| Pharmacokinetics: Prucalopride plasmaconcentrations | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Camilleri, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21039673 | Derived | Camilleri M, Van Outryve MJ, Beyens G, Kerstens R, Robinson P, Vandeplassche L. Clinical trial: the efficacy of open-label prucalopride treatment in patients with chronic constipation - follow-up of patients from the pivotal studies. Aliment Pharmacol Ther. 2010 Nov;32(9):1113-23. doi: 10.1111/j.1365-2036.2010.04455.x. Epub 2010 Sep 16. |
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| ID | Term |
|---|---|
| C406662 | prucalopride |
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