Constipation Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Tolerability of Oral Once-Daily Prucalopride (R108512) Solution in Constipated Elderly Subjects Living in a Nursing Facility
Verified date | January 2008 |
Source | Movetis |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 2000 |
Est. primary completion date | May 2000 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Movetis |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient's Global Assessment of severity of constipation and efficacy of treatment evaluated (for exploratory reasons only). | 4 weeks | No | |
Secondary | Patient's symptom assessment(evaluated for exploratory reasons only). | 4 weeks | No |
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