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Study of the Research Medicine CIN-103 in Adults With Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D).

Irritable Bowel Syndrome With Diarrhea Clinical Trial

Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of CIN-103 in Adults With Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06153420
Study type Interventional
Source CinPhloro Pharma, LLC
Contact Lauren Brown
Phone +1.513.579.9911
Email L.brown@medpace.com
Status Recruiting
Phase Phase 2
Start date December 28, 2023
Completion date May 4, 2025
View Details
See also
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