Evaluation of the Safety and Tolerability of Prucalopride in Constipated Elderly Subjects Living in a Nursing Facility

• Status: Completed
• Trial end date: 2000-05-01
• Target enrollment: 0
• Participant gender: All

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 a dose of 4 mg once daily is safe and well tolerated in in elderly subjects living in a nursing facility.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Movetis
• Treatments: Prucalopride

Criteria

Inclusion Criteria:

1. Male and female patients at least 65 years of age (no upper age limit).

2. 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.

3. The patient had to live in a nursing facility.

4. The patient had to be clinically stable.

5. The patient had to be able to take oral medications.

6. The patient had to be continent of bowels the majority of time.

7. The patient had to be able to reliably communicate AEs.

8. The patient had to provide informed consent, signed by the patient or legally acceptable representative and by the investigator.

Exclusion Criteria:

1. Patients who were known to be HIV positive or who had AIDS.

2. Patients who were being actively treated with Propulsid (cisapride) or cancer chemotherapy other than hormonal agents.

3. 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.

4. Patients who received an investigational drug in the 30 days preceding the study.

5. Patients who had previously received either R093877 or R108512.