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

Primary Purpose

Irritable Bowel Syndrome With Diarrhea

Status
Not yet recruiting
Phase
Phase 2
Locations
Vietnam
Study Type
Interventional
Intervention
DT01 tablets
Placebo tablets
DT01-Placebo tablets
Sponsored by
Centre of Clinical Pharmacology, Hanoi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Diarrhea

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Military Institute of Traditional Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo tablets

DT01 tablets

DT01-Placebo tablets

Arm Description

Posology: oral administration of 3 placebo tablets three times per day for 8 weeks.

Posology: oral administration of 3 DT01 tablets three times per day for 8 weeks.

Posology: oral administration of 2 DT01 tablets and 1 placebo tablet, three times per day for 8 weeks.

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 10, 2022
Last Updated
January 30, 2023
Sponsor
Centre of Clinical Pharmacology, Hanoi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05719896
Brief Title
Efficacy and Safety of DT01 Tablets in Patients With Irritable Bowel Syndrome With Diarrhea
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre of Clinical Pharmacology, Hanoi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Diarrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo tablets
Arm Type
Placebo Comparator
Arm Description
Posology: oral administration of 3 placebo tablets three times per day for 8 weeks.
Arm Title
DT01 tablets
Arm Type
Experimental
Arm Description
Posology: oral administration of 3 DT01 tablets three times per day for 8 weeks.
Arm Title
DT01-Placebo tablets
Arm Type
Experimental
Arm Description
Posology: oral administration of 2 DT01 tablets and 1 placebo tablet, three times per day for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
DT01 tablets
Intervention Description
Each subject was given orally 3 DT01 tablets/day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo tablets
Intervention Description
Each subject was given orally 3 DT01 tablets/day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
DT01-Placebo tablets
Intervention Description
Each subject was given orally 2 DT01 tablets and 1 Placebo tablet, three times per day for 8 weeks
Primary Outcome Measure Information:
Title
Abdominal pain response
Description
Decrease in the weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline
Time Frame
8 weeks
Title
Stool consistency response
Description
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.
Time Frame
8 weeks
Title
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)
Description
A participant must meet both of the Abdominal pain response and Stool consistency response in the same week to be a weekly responder.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Centre of Clinical Pharmacology
Phone
+84 24 3852 3798
Ext
3188
Email
duoclylamsang@gmail.com
Facility Information:
Facility Name
Military Institute of Traditional Medicine
City
Hanoi
Country
Vietnam
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Military Institute of Traditional Medicine
Phone
+84 2438583135
Email
admin@yhoccotruyenqd.vn

12. IPD Sharing Statement

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

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