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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT01494233
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects, aged 18 to 70 years, with diarrhea-predominant IBS (IBS-D) with symptom onset at least 6 months prior to diagnosis
* Two or more days per week with at least one stool with a consistency of Type 6 or 7 (Bristol Stool Form Scale)
* Weekly average of worst abdominal pain in past 24 hours score of greater than or equal to 3.0 using a 0-10 point scale
* Ability to provide written, informed consent
Exclusion Criteria:
* Inability to discontinue any current drug therapy for IBS, with the exception of bulking agents. Subjects will be allowed up to 2 doses of loperamide per week as rescue medication.
* Subjects who score severe abdominal pain (rated 7 or higher) 5 or more days per week
* Concomitant use of opioid analgesic drugs or drugs that affect bowel motility
* Any abnormalities or conditions deemed by the investigator as clinically significant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01494233
Study Brief:
Protocol Section:
NCT01494233