Study of the Research Medicine CIN-103 in Adults With Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D).
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Irritable Bowel Syndrome With Diarrhea
In brief
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.
Key facts
- Study ID
- NCT06153420
- Run by
- CinPhloro Pharma, LLC
- People needed
- 421
- Starts
- 2023-12-28
- Expected to finish
- 2025-07-28
- Last updated by the study team
- 2025-12-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Clinical Research Associates, LLC — Huntsville, Alabama, United States
- Elite Clinical Studies LLC — Phoenix, Arizona, United States
- GI Alliance - Sun City — Sun City, Arizona, United States
- Applied Research Center of Arkansas — Little Rock, Arkansas, United States
- Paragon Rx Clinical, Inc. - Garden Grove — Garden Grove, California, United States
- Gastro Care Institute- lancaster — Lancaster, California, United States
- Medical Associates Research Group — San Diego, California, United States
- American Family Research Group — Cape Coral, Florida, United States
- USA and International Research Inc. — Doral, Florida, United States
- International Research Associates LLC — Miami, Florida, United States
- Innovation Medical Research Center — Palmetto Bay, Florida, United States
- Velocity Clinical Research,, Savannah — Savannah, Georgia, United States
- Southwest Gastroenterology — Oak Lawn, Illinois, United States
- DelRicht Research — Mandeville, Louisiana, United States
- Tandem Clinical Research GI LLC — Marrero, Louisiana, United States
- Tandem Clinical Research GI LLC — Metairie, Louisiana, United States
- DelRicht Research — New Orleans, Louisiana, United States
- Delta Research Partners, LLC — West Monroe, Louisiana, United States
- DelRicht Research of Bethesda Clinical Trials — Rockville, Maryland, United States
- St. Charles Clinical Research — Weldon Spring, Missouri, United States
- Quality Clinical Research, Inc — Omaha, Nebraska, United States
- Las Vegas Medical Research — Las Vegas, Nevada, United States
- Digestive Disease Specialists — Las Vegas, Nevada, United States
- Advanced Research Institute - Reno — Reno, Nevada, United States
- Digestive Health Specialists - Dothan — Dothan, Alabama, United States
Full record on ClinicalTrials.gov
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