NCT05719896

Efficacy and Safety of DT01 Tablets in Patients With Irritable Bowel Syndrome With Diarrhea

A Phase II, Double-blind, Randomized, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of DT01 Tablets in Patients With Irritable Bowel Syndrome With Diarrhea

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Centre of Clinical Pharmacology, Hanoi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, double-blind, randomized, 3-arm, placebo-controlled study to evaluate the efficacy and describe the safety of DT01 tablets in adults with IBS-D. Patients who meet all entry criteria will be randomized to receive DT tablets or placebo or both for 8 weeks. The study drug will be taken three times daily. Investigators will conduct phone-based assessments on Days 7, 14, 21, 28, 35, 42, 49. Patients will return to the clinic after dosing has completed (Day 56) for a follow-up visit.

Conditions

• Irritable Bowel Syndrome With Diarrhea

Interventions

Type	Name	Description
DRUG	DT01 tablets	Each subject was given orally 3 DT01 tablets/day for 8 weeks
DRUG	Placebo tablets	Each subject was given orally 3 DT01 tablets/day for 8 weeks
DRUG	DT01-Placebo tablets	Each subject was given orally 2 DT01 tablets and 1 Placebo tablet, three times per day for 8 weeks

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-02-09
• Last updated: 2023-02-09

Locations

1 site across 1 country: Vietnam