Clinical Trials Logo

Clinical Trial Summary

This study will evaluate the effects of ORP-101 versus placebo on stool consistency and abdominal pain in patients with Irritable Bowel Syndrome with Diarrhea (IBS-D). It will also assess the safety and tolerability of ORP-101 in patients with IBS-D.


Clinical Trial Description

The objectives of this study are to evaluate the efficacy, safety and tolerability of ORP-101 in patients with IBS-D. This is a randomized, double-blind, placebo-controlled, 3-arm, 12-week, parallel proof-of-concept study with 2 active arms (50 mg and 100 mg ORP-101, QD) and 1 matching placebo arm, using a responsive adaptive randomization approach. After screening, patients who qualify will enter the baseline symptom assessment period, during which they will be instructed on completion of an electronic diary for daily collection of data related to their IBS symptoms, bowel function and loperamide rescue usage (not allowed during baseline). Patients who meet all entry criteria will be randomized to receive one of two different doses of ORP-101 tablets or placebo for 12 weeks. The study drug will be taken once daily, approximately 30 minutes prior to breakfast. Patients will return to the clinic on Days 14, 28, 56, 84 (12 weeks) and 2 weeks after dosing has completed (Day 98) for a follow-up visit. Study subjects will include both male and female adults. Approximately 320 patients with IBS-D will be randomized to receive study drug or placebo. Randomization will be stratified by history of cholecystectomy/gallbladder agenesis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04129619
Study type Interventional
Source OrphoMed, Inc.
Contact
Status Completed
Phase Phase 2
Start date November 22, 2019
Completion date October 4, 2021

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Withdrawn NCT02320318 - 12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 3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
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
Terminated NCT02120027 - 52-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 3
Completed NCT02107196 - 12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 3