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:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-26 @ 2:38 PM
NCT ID:
NCT06854406
Eligibility Criteria:
Inclusion Criteria:
1. Participants will be 18-70 years of age
2. Irritable bowel syndrome with pain, but no constipation \[that is IBS-D (diarrhea), IBS-M (mixed), or IBS-U (unspecified)\]
Exclusion Criteria:
1. Diagnosis of moderate-severe depression as per HADS\>8
2. Alcohol or illicit substance dependence or abuse in the past 12 months
3. Dementia, unprovoked seizure history, seizure disorder
4. Pregnancy (all women of childbearing potential will be required to have a negative pregnancy test prior to initiation, and will be on a highly effective method of contraception, as detailed in the consent form)
5. Significant change or increase in antidepressant or pain medications within the last four weeks; significant change in primary treatment interventions for pain in the past four weeks
6. Medically unstable
7. Severe hepatic or renal impairment, such as baseline AST or ALT \>2.5 X upper normal limit or end-stage renal disease with estimated glomerular filtration rate or creatinine clearance \<15 mL/min
8. Concomitant use of strong CYP3A4 inhibitors and strong or moderate CYP3A4 inducers
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 12/27/2024. Questions regarding updates should be directed to the study team contact.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06854406
Study Brief:
Protocol Section:
NCT06854406