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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07382167
Eligibility Criteria:
Inclusion Criteria:
1. Patients ≥18 to ≤80 years old at the Screening visit (Visit 1).
2. Meet the Rome IV Diagnostic Criteria for functional constipation.
3. Females of non-childbearing potential, or agree to the use of an acceptable means of contraception for up to 30 days following the last dose of study medication.
4. Males must agree to use an appropriate method of barrier contraception or have documented surgical sterilization.
5. Meets the entry criteria assessed during the Screening period.
6. Ability to understand and provide input on the assessments in the eDiary.
7. Provide written informed consent before the initiation of any study-specific procedures.
8. Must agree to have daily access to eDiary via a computer, tablet or smart phone
Exclusion Criteria:
1. Loose or watery stool in the absence of any medication that is known to affect stool consistency for \>25% of bowel movements (BMs) during the 3 months prior to the Screening visit
2. Fecal impaction within 6 months prior to the Screening visit
3. Unexplained and clinically significant alarm symptoms.
4. Functional diarrhea as defined by Rome IV criteria
5. IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), mixed IBS (IBS-M), or unsubtyped IBS as defined by Rome IV criteria
6. Diagnosis or treatment of any clinically symptomatic abnormality of the GI tract or active disease within 6 months prior to the Screening visit
7. Patient with central nervous system disorder
8. Use of prohibited medications defined by protocol
9. Patient has a history or current evidence of laxative abuse
10. Hepatic dysfunction
11. Positive HIV, hepatitis B or hepatitis C test at screening
12. Positive urinary drug test at Screening, with the exception of cannabis and cannabidiol (CBD)
13. Any evidence of or treatment of malignancy within 1 year prior to the Screening visit
14. Any surgery on the stomach, small intestine or colon; appendectomy or cholecystectomy are not excluded unless within 60 days prior to the Screening visit
15. Pregnant women or women planning to become pregnant during trial participation
16. A major psychiatric disorder that has required hospitalization in the last year prior to the Screening visit.
17. Alcohol or substance abuse within 1 year prior to the Screening visit
18. Participation in other clinical trials within 1 month prior to the Screening visit
19. Clinical evidence of significant disease that may interfere with the patient's successful completion of the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07382167
Study Brief:
Protocol Section:
NCT07382167