TerminatedPhase 2

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

Stopped: The study was terminated due to lack of efficacy compared to placebo.

United States421 participantsStarted 2023-12-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Are adult male and female subjects ≥ 18 years of age;
✓. Have a body mass index between 18 and 45 kg/m2, inclusive at Screening;
✓. Meet Rome IV Criteria for IBS-D by subject self-report of recurrent abdominal pain that is associated with ≥ 2 of the following over the last ≥ 6 months, with frequency of at least 1 day per week over the last 3 months (on average) before enrollment:
✓. Related to defecation;
✓. Associated with a change in frequency of stool; and/or
✓. Associated with a change in form (appearance of stool).
✓. Based on Investigator interview of subject's symptoms over the last 3 months, have ≥ 25% of bowel movements (BMs) with Bristol Stool Scale (BSS) Type 6 or 7 (loose or watery stools) and \< 25% of BMs with BSS Type 1 or 2 (lumpy or hard stools) per the Rome IV Criteria for IBS-D;
✓. In the opinion of the Investigator, are on a stable diet for ≥ 4 weeks prior to Screening and are not planning to change lifestyle, exercise, and/or diet that may impact symptoms of IBS-D during study participation;

Exclusion criteria

What they're measuring

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

Timeframe: 12 weeks of Double Blind Treatment Period

Trial details

NCT IDNCT06153420

SponsorCinPhloro Pharma, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-28

View on ClinicalTrials.gov More Irritable Bowel Syndrome With Diarrhea trials