Irritable Bowel Syndrome With Diarrhea Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled, Phase 2, Responsive Adaptive Randomization Study of ORP-101 in Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)
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.
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. ;
| 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| Withdrawn |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 | |
| Completed |
NCT02107196 -
12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)
|
Phase 3 | |
| Terminated |
NCT02120027 -
52-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)
|
Phase 3 |