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:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT00816205
Eligibility Criteria:
Inclusion Criteria:
Subjects meeting the following criteria will be eligible to participate in the trial:
* Signed written informed consent;
* Male or female subjects 18 to 55 years of age;
Exclusion Criteria:
Subjects are excluded from participation in the study if any of the following criteria apply:
Has a clinically significant history or presence of any of the following conditions:
* Known allergy to Nifedipine, polyethylene-glycol, Propylene-glycol or silicone.
* Active or past history of disease that requires medication or clinical follow up.
* Malignant disease within 5 years of screening;
* History of ano rectal disease.
* History of gastrointestinal disease.
* History of gastrointestinal bleeding.
* History of rectal surgery.
* History of gastrointestinal surgery.
* History of HIV.
* In need of chronic use of medication, with the exception of birth control medications.
* Currently uses medication for acute illness.
* Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion.
* Has received any investigational drug within 90 days of screening;
* Receipt of any investigational treatment (drug or device) within 90 days prior to screening;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00816205
Study Brief:
Protocol Section:
NCT00816205