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

NCT05719896 | Unknown Phase 2

• 1 other identifier: AC001-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome With Diarrhea

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  8 weeks

Study Arms (3)

Placebo tablets

PLACEBO COMPARATOR

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

Drug: Placebo tablets

DT01 tablets

EXPERIMENTAL

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

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.

Drug: DT01-Placebo tablets

Interventions

DT01 tablets DRUG

Each subject was given orally 3 DT01 tablets/day for 8 weeks

DT01 tablets

Placebo tablets DRUG

Each subject was given orally 3 DT01 tablets/day for 8 weeks

Placebo tablets

DT01-Placebo tablets DRUG

Each subject was given orally 2 DT01 tablets and 1 Placebo tablet, three times per day for 8 weeks

DT01-Placebo tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre of Clinical Pharmacology, Hanoi Medical University: lead

Study Sites (1)

Military Institute of Traditional Medicine

Hanoi, Vietnam

Location

Central Study Contacts

Centre of Clinical Pharmacology

CONTACT

+84 24 3852 3798; duoclylamsang@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: February 9, 2023
• Study Start: February 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 9, 2023

Record last verified: 2022-12

Locations

VN (1)