Status:
COMPLETED
Evaluation of the Safety and Tolerability of Prucalopride in Constipated Elderly Subjects Living in a Nursing Facility
Lead Sponsor:
Movetis
Conditions:
Constipation
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of constipation in elderly subjects living in a nursing facility. Hypothesis: Prucalopride up to...
Detailed Description
This is a multicenter, Phase II, dose-escalation trial with a 4 week double-blind, placebo-controlled treatment period. There will be four treatment cohorts (0.5 mg, 1 mg, 2 mg, or 4 mg) with 25 subje...
Eligibility Criteria
Inclusion
- Male and female patients at least 65 years of age (no upper age limit).
- History of constipation. i.e., the patient should have received any treatment for constipation at any time during the 4 weeks (28 days) preceding entry into the study, including fibre/bulk forming supplements.
- The patient had to live in a nursing facility.
- The patient had to be clinically stable.
- The patient had to be able to take oral medications.
- The patient had to be continent of bowels the majority of time.
- The patient had to be able to reliably communicate AEs.
- The patient had to provide informed consent, signed by the patient or legally acceptable representative and by the investigator.
Exclusion
- Patients who were known to be HIV positive or who had AIDS.
- Patients who were being actively treated with Propulsid (cisapride) or cancer chemotherapy other than hormonal agents.
- Patients with significantly impaired renal function, i.e., creatinine clearance \<30 mL/min using the Cockcroft and Gault formula:
- Males: CLCR = \[(140-age) x (weight in kg)\] / 72 x (SCR).
- Females: CLCR = male value x 0.85
- Because the calculated value for creatinine clearance could be artificially high when serum creatinine concentrations were very low, patients with a serum creatinine \<0.5 mg/dL were excluded from the study.
- Patients who received an investigational drug in the 30 days preceding the study.
- Patients who had previously received either R093877 or R108512.
Key Trial Info
Start Date :
February 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2000
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00627692
Start Date
February 1 1999
End Date
May 1 2000
Last Update
May 29 2008
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