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 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT02621892
Eligibility Criteria:
Inclusion Criteria:
* 18 to 75 years old
* Females must be of non-childbearing potential; If of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception.
* Males must agree to use an appropriate method of barrier contraception or have documented surgical sterilization
* Subject meets definition of IBS-C using Rome III Criteria for the Diagnosis of IBS
* A colonoscopy based on AGA guidelines; every 10 years at ≥ 50 years old, or the occurrence of any warning signs
Exclusion Criteria:
* Functional diarrhea as defined by Rome III criteria
* IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome III criteria
* Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract within 6 months prior to screening, or active disease within 6 months prior to screening; including but not limited to cancer, inflammatory bowel disease, diverticulitis, duodenal ulcer, erosive esophagitis, gastric ulcer, pancreatitis (within 12 months of screening), cholelithiasis, amyloidosis, ileus, non-controlled GERD, gastrointestinal obstruction, ischemic colitis or carcinoid syndrome.
* Subject has a history or current evidence of laxative abuse (in the clinical judgment of the physician)
* Hepatic dysfunction (ALT \[SGPT\] or AST \[SGOT\] \>2.5 times the upper limit of normal) or renal impairment (serum creatinine \> 2mg/dL)
* Any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous year
* Any surgery on the stomach, small intestine or colon, excluding appendectomy or cholecystectomy (unless within 60 days of screening visit)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02621892
Study Brief:
Protocol Section:
NCT02621892