Clinical Trials Logo
  1. Home
  2. Other
  3. NCT06153420

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

Irritable Bowel Syndrome With Diarrhea Clinical Trial

Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of CIN-103 in Adults With Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06153420
Study type Interventional
Source CinPhloro Pharma, LLC
Contact Lauren Brown
Phone +1.513.579.9911
Email L.brown@medpace.com
Status Recruiting
Phase Phase 2
Start date December 28, 2023
Completion date May 4, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT00552565 - Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 3
Completed NCT04950296 - To Study the Efficacy and Safety of L. Plantarum UALp-05TM in Diarrhea- Predominant-irritable Bowel Syndrome N/A
Completed NCT02959983 - Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use Phase 4
Withdrawn NCT02320318 - 12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 3
Completed NCT01303224 - Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D) Phase 2
Recruiting NCT05646186 - Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome N/A
Recruiting NCT03806959 - Interest of Pan-capsule in Symptomatic Patients Suspected of Irritable Bowel Syndrome Requiring Colonoscopy N/A
Completed NCT04129619 - A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 2
Recruiting NCT04855799 - GI Permeability Change in Response to Aquamin® Phase 2
Completed NCT04662957 - Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome N/A
Completed NCT04557215 - Efficacy and Safety of Rifaximin With NAC in IBS-D Phase 1/Phase 2
Enrolling by invitation NCT05311293 - Study on the Molecular Mechanism of Diarrhea-predominant Irritable Bowel Syndrome With Anxiety and Depression Based on Multi-omics Correlation Analysis
Completed NCT05277428 - Clinical Study to Evaluate the IBS Symptoms Improving Effect and Safety of GTB1 N/A
Not yet recruiting NCT03221790 - Effect of FODMAPs on Mucosal Inflammation in IBS Patients N/A
Completed NCT03557788 - Changes in Microbiota and Metabolomic Profile Between Rifaximin Responders and Non-responders In Diarrhoea-Predominant Irritable Bowel Syndrome Phase 4
Completed NCT02757105 - Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D) Phase 2
Enrolling by invitation NCT06432569 - Evaluation of Butyrate and Palmitoylethanolamide in IBS Patients (B/P3_1) N/A
Recruiting NCT04830410 - The Effects of Carbohydrates in Irritable Bowel Syndrome N/A
Completed NCT03245645 - FODMAP Reintroduction in Irritable Bowel Syndrome N/A
Completed NCT02107196 - 12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 3