NCT06153420

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

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 421 (actual)
• Sponsor: CinPhloro Pharma, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome With Diarrhea

Interventions

Type	Name	Description
DRUG	CIN-103	CIN-103 BID
DRUG	Placebo	Placebo for CIN-103 BID

Timeline

• Start date: 2023-12-28
• Primary completion: 2025-07-28
• Completion: 2025-07-28
• First posted: 2023-12-01
• Last updated: 2025-12-15

Locations

53 sites across 1 country: United States

Regulatory

• FDA-regulated drug study