Efficacy and Safety of DT01 Tablets in Patients With Irritable Bowel Syndrome With Diarrhea (NCT05719896) | Clinical Trial Compass
UnknownPhase 2
Efficacy and Safety of DT01 Tablets in Patients With Irritable Bowel Syndrome With Diarrhea
Vietnam120 participantsStarted 2023-02
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. A weekly average of worst abdominal pain in the past 24 hours with a score of ≥ 3.0 according to the Visual Analogue Scale (VAS).
. At least one bowel movement on each day.
. A weekly average of at least 3 bowel movements per day.
. At least one stool with a consistency of Type 6 or Type 7 according to the Bristol Stool Scale (BSS) on at least 2 days per week.
. Less than 2 bowel movements with a consistency of Type 1 or Type 2 according to the BSS per week.
. Adequate compliance with the diary recording procedure defined as at least ≥80% of the nominal daily data entry.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Abdominal pain response
Timeframe: 8 weeks
2
Stool consistency response
Timeframe: 8 weeks
3
Weekly response for abdominal pain intensity and stool consistency over 8 weeks of treatment in at least 50% of the weeks of treatment (4 out of 8 weeks)
Timeframe: 8 weeks
Trial details
NCT IDNCT05719896
SponsorCentre of Clinical Pharmacology, Hanoi Medical University