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 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT00948818
Eligibility Criteria:
Inclusion Criteria:
* Patient meets protocol criteria for IBS: reports abdominal discomfort or pain that has two or more of the following three features:
1. Relieved with defecation
2. Onset associated with a change in frequency of stool
3. Onset associated with a change in form (appearance) of stool
* Patient reports \< 3 bowel movements (BMs) per week (in the absence of any laxative, suppository, or enema use during the preceding 24 hours) and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during \> 25% of BMs
* Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests (some patients may require a colonoscopy per American Gastroenterological Association (AGA) guidelines)
* Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting of BM habits and IBS symptoms
Exclusion Criteria:
* Patient has history of loose or watery stools for \>25% of BMs
* Patient has a structural abnormality of the gastrointestinal (GI) tract or a history of a disease or condition that can affect GI motility
* Patient has any protocol-excluded or clinically significant medical or surgical history or concomitant medication use that could confound the study assessments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00948818
Study Brief:
Protocol Section:
NCT00948818