Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-24 @ 3:23 PM
NCT ID:
NCT00627692
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT00627692
Study Brief:
Protocol Section:
NCT00627692