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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT00258193
Eligibility Criteria:
Inclusion Criteria:
* Patient agrees to use a medically accepted, double-barrier form of contraception (e.g., IUD and condom) during participation;
* No evidence of pelvic floor dysfunction and the completion of a negative digital rectal exam prior to the first dose of study medication;
* Absence of an evacuation disorder as defined per protocol;
* Patients must meet ROME II Criteria for C-IBS;
* The patient's Baseline Colonic Transit Test must show a geometric center (GC) ≤ 2.65 at 24 hours, or ≤ 3.0 at 24 hours and ≤ 3.9 at 48 hours.
Exclusion Criteria:
* History of clinically-significant manifestations of any major system organ class;
* History of inflammatory bowel disease or gastric ulcers;
* Significant GI surgery within 6 months;
* Clinically-significant prolonged diarrhea within 60 days;
* Special dietary habit and/or an intense physical workout program within 4 weeks;
* Certain drug hypersensitivities
* History of alcoholism or drug addiction within 12 months;
* Receipt of an investigational drug during the study or within 30 days;
* Use of any prescription medication or OTC, non-prescription medications disallowed by the protocol within 7 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00258193
Study Brief:
Protocol Section:
NCT00258193