CIN-103 for Irritable Bowel Syndrome

Verified Trial

Phase 2

Recruiting

Research Sponsored by CinPhloro Pharma, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a body mass index between 18 and 40 kg/m2, inclusive at Screening;

In the last 6 months have you had abdominal pain that's related to a bowel movement?

Must not have

Diagnosis or suspected diagnosis of IBS with subtype other than IBS-D

You have been diagnosed with Congestive Heart Failure

Timeline

Screening 3 days

Treatment Varies

Follow Up through study completion, up to 19 weeks.

Summary

This trial aims to see if a new drug, CIN-103, can help adults with irritable bowel syndrome with predominant diarrhea (IBS-D). They want to know if the drug is better

Who is the study for?

Adults over 18 with IBS-D who have a stable diet and aren't planning lifestyle changes that could affect their symptoms. They should have a BMI between 18-40, normal colon cancer screening results based on age, and no significant history of colorectal polyps or other conditions that might interfere with the study.

What is being tested?

The trial is testing CIN-103 against a placebo to see if it reduces IBS-D symptoms like abdominal pain and diarrhea. Participants will take the drug or placebo twice daily for 12 weeks and track their symptoms in diaries.

What are the potential side effects?

While specific side effects are not listed here, the trial aims to assess how well patients tolerate CIN-103 compared to a placebo, which includes monitoring any adverse reactions participants may experience during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

Your body mass index (BMI) is between 18 and 40.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with IBS, but not the diarrhea-predominant type.

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ through study completion, up to 19 weeks.

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~through study completion, up to 19 weeks.

This trial's timeline: 3 days for screening, Varies for treatment, and through study completion, up to 19 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurrence of meeting Study Composite Responder status for an adult subject with IBS-D.

Secondary study objectives

Incidence of clinically significant changes, in the Investigator's opinion, in vital signs, physical examinations, ECGs, and clinical laboratory evaluations.

Occurrence of TEAEs leading to premature discontinuation of the study drug.

Occurrence of Treatment-Emergent Adverse Events (TEAEs).

+14 more