- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Centre of Clinical Pharmacology
- Phone Number: 3188 +84 24 3852 3798
- Email: duoclylamsang@gmail.com
Study Locations
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Hanoi, Vietnam
- Military Institute of Traditional Medicine
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Contact:
- Military Institute of Traditional Medicine
- Phone Number: +84 2438583135
- Email: admin@yhoccotruyenqd.vn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: Placebo tablets
Posology: oral administration of 3 placebo tablets three times per day for 8 weeks.
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Each subject was given orally 3 DT01 tablets/day for 8 weeks
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EXPERIMENTAL: DT01 tablets
Posology: oral administration of 3 DT01 tablets three times per day for 8 weeks.
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Each subject was given orally 3 DT01 tablets/day for 8 weeks
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EXPERIMENTAL: DT01-Placebo tablets
Posology: oral administration of 2 DT01 tablets and 1 placebo tablet, three times per day for 8 weeks.
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Each subject was given orally 2 DT01 tablets and 1 Placebo tablet, three times per day for 8 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abdominal pain response
Time Frame: 8 weeks
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Decrease in the weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline
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8 weeks
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Stool consistency response
Time Frame: 8 weeks
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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.
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8 weeks
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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
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A participant must meet both of the Abdominal pain response and Stool consistency response in the same week to be a weekly responder.
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8 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AC001-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Irritable Bowel Syndrome With Diarrhea
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ProgenaBiomeRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
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Federal Stare Budgetary Scientific Institution,...I.M. Sechenov First Moscow State Medical University; RML INVEST, Torkhovsky...CompletedIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedRussian Federation
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Istanbul Medipol University HospitalTepecik Training and Research Hospital; Bozyaka Training and Research Hospital and other collaboratorsRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedTurkey
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I.M. Sechenov First Moscow State Medical UniversityActive, not recruitingIrritable Bowel Syndrome With DiarrheaRussian Federation
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