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CIN-103 BID Dose 2 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.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of meeting Study Composite Responder status for an adult subject with IBS-D.
Secondary outcome measures
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

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: CIN-103 BID Dose 2Experimental Treatment1 Intervention
CIN-103 Dose 2, administered as 4 x CIN-103 capsules per dose. Two doses per day.
Group II: CIN-103 BID Dose 1Experimental Treatment1 Intervention
CIN-103 Dose 1, administered as 2 x CIN-103 capsules and 2 x matching placebo per dose. Two doses per day.
Group III: Placebo for CIN-103 BIDPlacebo Group1 Intervention
Placebo for CIN-103, administered as 4 x matching placebo capsules per dose. Two doses per day.

Find a Location

Who is running the clinical trial?

CinPhloro Pharma, LLCLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many distinct clinics is this experimental investigation currently being conducted?

"At present, this research endeavor is actively enrolling participants from 18 different locations. Among these are centers situated in Mentor, Metairie, and Phoenix along with numerous other sites. Enrolling at the nearest site to your residence is advisable to reduce travel obligations if you decide to participate."

Answered by AI

Are there any ongoing efforts to enroll participants for this study?

"As indicated on clinicaltrials.gov, this specific trial is actively enrolling subjects. The trial was first listed on 12/28/2023 and its most recent update was recorded on 2/7/2024."

Answered by AI

What is the current number of participants involved in this clinical study?

"This study requires the enrollment of 450 eligible candidates. Patients meeting the defined criteria can choose to join from various locations, including Great Lakes Gastroenterology Research LLC in Mentor, Ohio and Tandem Clinical Research GI LLC in Metairie, Louisiana."

Answered by AI

What are the risks associated with administering CIN-103 BID Dose 2 to individuals?

"The safety ranking for CIN-103 BID Dose 2 has been assessed as a 2 by our team at Power. This rating reflects the ongoing Phase 2 trial where some safety data is available, although there is no evidence yet supporting efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Other
Albuquerque Clinical Trials, Inc
Advanced Research Institute
Quality Clinical Research, Inc
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

To help find a curr. IBS c and D all my life. I haven't tried any drugs yet.
PatientReceived 2+ prior treatments
Integrity Linzess Sugar liquid. Suffering for many years with ins.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Quality Clinical Research, Inc: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study of the Research Medicine CIN-103 in Adults With Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D).
2023. "Study of the Research Medicine CIN-103 in Adults With Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06153420.
All > Irritable Bowel Syndrome > New Orleans
~300 spots leftby Feb 2025
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