Study of the Research Medicine CIN-103 in Adults With Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D).
Status:
Recruiting
Trial end date:
2025-05-04
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to evaluate if the study drug, CIN-103, can help reduce
the symptoms associated with irritable bowel syndrome with predominant diarrhea (IBS-D) in
adult patients. The main questions it aims to answer are:
- To evaluate the efficacy of CIN-103 on symptoms of IBS-D when given to patients with
IBS-D compared to a placebo.
- To evaluate the safety and tolerability of CIN-103 when given to patients with IBS-D
compared to a placebo
Participants will attend the following visits:
- Screening Period (1 Visit)
- Baseline Period (1 Visit)
- Will complete daily diary and other Patient Reported Outcomes (PROs) as described
in the protocol to assess eligibility for continued participation.
- 12-Week Treatment Period (5 Visits)
- Study drug taken twice daily by mouth.
- Will complete daily diaries and other PROs as described in the protocol.
- Follow- Up Period (1 Visit)
Researchers will compare CIN-103 Dose 1, CIN-103 Dose 2, and placebo, to evaluate the
clinical response to multiple dose strengths of CIN-103 relative to placebo on abdominal pain
and stool consistency along with safety and tolerability.