Irritable Bowel Syndrome With DiarrheaPhase 2NCT05719896
Efficacy and Safety of DT01 Tablets in Patients With Irritable Bowel Syndrome With Diarrhea
A Phase 2 study testing DT01 tablets in people with Irritable Bowel Syndrome With Diarrhea, run by Centre of Clinical Pharmacology, Hanoi Medical University at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- DT01 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteVietnam
- Study dates
- Feb 2023to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older.
- Has a diagnosis of IBS-D (Irritable Bowel Syndrome with Diarrhea) and meets the Rome IV Criteria
- Additional criterion: more than 3 bowel movements per day at least 25% of the time in the last 3 months.
- For patients older than 50 years OR patients with a positive family history of colorectal cancer: Normal results from colonoscopy/flexible sigmoidoscopy performed within the last 2 years.
- For patients aged 65 years or older: Absence of ischaemic colitis, microscopy colitis or any other organic gastrointestinal disease as evidenced by the results of a colonoscopy/flexible sigmoidoscopy with biopsy performed within 12 months.
- Mentally competent, able to give written informed consent, and compliant to undergo all visits and procedures.
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- Unrestricted access to a touch-tone telephone.
- Willingness to refrain from using loperamide within 3 days prior to run-in visit and during the run-in period.
- For women of childbearing potential: Use of a highly effective contraceptive method with a failure rate <1% per year throughout the entire study period.
- Additional criteria at randomisation: During both weeks of the run-in period:
- 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.
Who cannot join
- Diagnosis of IBS with a subtype of constipation, mixed IBS, or un-subtyped IBS.
- History of organic GI abnormalities, inflammatory bowel diseases, complicated diverticulosis, ischaemic colitis, microscopic colitis.
- History of pancreatitis, active biliary duct disease, cholecystitis or symptomatic gallbladder stone disease in the previous 6 months.
- History of gluten enteropathy or lactose intolerance.
- Hypersensitivity to the active substances or to any of the excipients of study drug or placebo.
- History of major cardiovascular events in the previous 6 months.
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- History of human immunodeficiency virus infection.
- Uncontrolled hypertension, insulin-dependent diabetes mellitus or abnormal thyroid function.
- Evidence of clinically significant hepatic disease, severe renal insufficiency or anemia.
- Use of prohibited concurrent medication within the previous month such as antibiotics, antimuscarinic drugs, drugs enhancing GI motility and analgesics.
- Pregnancy or breastfeeding.
- Inability to understand or collaborate throughout the study.
- Participation in other clinical studies in the previous 4 weeks or concomitant enrollment in a clinical study.
- Any condition that would compromise the well-being of the patient.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Military Institute of Traditional Medicine
Hanoi
Military Institute of Traditional Medicine, +84 2438583135, admin@yhoccotruyenqd.vn
About this study
Official title: 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
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
- Being tested
- DT01 tablets, Placebo tablets, DT01-Placebo tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT01 tabletsDrug
Each subject was given orally 3 DT01 tablets/day for 8 weeks
Placebo tabletsDrug
Each subject was given orally 3 DT01 tablets/day for 8 weeks
DT01-Placebo tabletsDrug
Each subject was given orally 2 DT01 tablets and 1 Placebo tablet, three times per day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo tablets | Placebo comparator | Posology: oral administration of 3 placebo tablets three times per day for 8 weeks. Receives: Drug: Placebo tablets |
| DT01 tablets | Experimental | Posology: oral administration of 3 DT01 tablets three times per day for 8 weeks. Receives: Drug: DT01 tablets |
| DT01-Placebo tablets | Experimental | Posology: oral administration of 2 DT01 tablets and 1 placebo tablet, three times per day for 8 weeks. Receives: Drug: DT01-Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pain response
Decrease in the weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline
Measured: 8 weeks
Stool consistency response
Decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 according to the Bristol Stool Scale (BSS) compared with baseline.
Measured: 8 weeks
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)
A participant must meet both of the Abdominal pain response and Stool consistency response in the same week to be a weekly responder.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre of Clinical Pharmacology, Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719896
- Sponsor's protocol ID
- AC001-1
- Status last verified
- Dec 2022
- First submitted
- 10 Dec 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05719896
- Acronym / sponsor ID
- AC001-1
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre of Clinical Pharmacology, Hanoi Medical UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo tablets | Placebo comparator | Drug: Placebo tabletsPosology: oral administration of 3 placebo tablets three times per day for 8 weeks. |
| DT01 tablets | Experimental | Drug: DT01 tabletsPosology: oral administration of 3 DT01 tablets three times per day for 8 weeks. |
| DT01-Placebo tablets | Experimental | Drug: DT01-Placebo tabletsPosology: oral administration of 2 DT01 tablets and 1 placebo tablet, three times per day for 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients aged 18 years or older.
- Has a diagnosis of IBS-D (Irritable Bowel Syndrome with Diarrhea) and meets the Rome IV Criteria
- Additional criterion: more than 3 bowel movements per day at least 25% of the time in the last 3 months.
- For patients older than 50 years OR patients with a positive family history of colorectal cancer: Normal results from colonoscopy/flexible sigmoidoscopy performed within the last 2 years.
- For patients aged 65 years or older: Absence of ischaemic colitis, microscopy colitis or any other organic gastrointestinal disease as evidenced by the results of a colonoscopy/flexible sigmoidoscopy with biopsy performed within 12 months.
Key exclusion criteria (14 listed)
- Diagnosis of IBS with a subtype of constipation, mixed IBS, or un-subtyped IBS.
- History of organic GI abnormalities, inflammatory bowel diseases, complicated diverticulosis, ischaemic colitis, microscopic colitis.
- History of pancreatitis, active biliary duct disease, cholecystitis or symptomatic gallbladder stone disease in the previous 6 months.
- History of gluten enteropathy or lactose intolerance.
- Hypersensitivity to the active substances or to any of the excipients of study drug or placebo.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DT01 tabletsEach subject was given orally 3 DT01 tablets/day for 8 weeks | Drug | DT01 tablets |
| Placebo tabletsEach subject was given orally 3 DT01 tablets/day for 8 weeks | Drug | Placebo tablets |
| DT01-Placebo tabletsEach subject was given orally 2 DT01 tablets and 1 Placebo tablet, three times per day for 8 weeks | Drug | DT01-Placebo tablets |
Primary outcome
Abdominal pain response
Time frame: 8 weeks
Decrease in the weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline
Stool consistency response
Time frame: 8 weeks
Decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 according to the Bristol Stool Scale (BSS) compared with baseline.
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)
Time frame: 8 weeks
A participant must meet both of the Abdominal pain response and Stool consistency response in the same week to be a weekly responder.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DT01 tablets in people with Irritable Bowel Syndrome With Diarrhea, run by Centre of Clinical Pharmacology, Hanoi Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Centre of Clinical Pharmacology (+84 24 3852 3798 ext. 3188, duoclylamsang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal pain response (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.