Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT06153420
Brief 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.
Study:
NCT06153420
Study Brief:
Protocol Section:
NCT06153420