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 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT02387359
Eligibility Criteria:
Inclusion Criteria:
•Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C
Exclusion Criteria:
* Refusal or inability to sign informed consent for the trial
* Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires
* BMI \> 35 or \< 18
* Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial
* Women who are pregnant or lactating
* Diagnosis of IBS-D or IBS-M
* Organic or obstructive disease of the small or large intestine
* Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)
* Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication
* Unstable medical illness
* Bilirubin \> 3X ULN in the absence of a conjugation defect
* Any laboratory value \> 3X ULN unless discussed and approved by the study Medical Monitor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02387359
Study Brief:
Protocol Section:
NCT02387359