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

NCT05719896 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-02-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Centre of Clinical Pharmacology, Hanoi Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05719896 on ClinicalTrials.gov