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

NCT06153420 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2025-12-15

No results posted yet for this study

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

DRUG

CIN-103

CIN-103 BID

DRUG

Placebo

Placebo for CIN-103 BID

Sponsors & Collaborators

CinPhloro Pharma, LLC
lead INDUSTRY

Study Design

Allocation: RANDOMIZED
Purpose: TREATMENT
Masking: DOUBLE
Model: PARALLEL

Eligibility

Min Age: 18 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2023-12-28
Primary Completion: 2025-07-28
Completion: 2025-07-28
FDA Drug: Yes

Countries

United States

Study Locations

More Related Trials

Entities

Drugs

Placebo