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

Irritable Bowel Syndrome With Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05719896
• Other study ID #: AC001-1
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2022
• Source: Centre of Clinical Pharmacology, Hanoi Medical University
• Contact: Centre of Clinical Pharmacology
• Phone: +84 24 3852 3798
• Email: duoclylamsang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

1. 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).

2. At least one bowel movement on each day.

3. A weekly average of at least 3 bowel movements per day.

4. 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.

5. Less than 2 bowel movements with a consistency of Type 1 or Type 2 according to the BSS per week.

6. 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.

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Diarrhea
• Syndrome

Intervention

Drug:
• DT01 tablets
Each subject was given orally 3 DT01 tablets/day for 8 weeks
• Placebo tablets
Each subject was given orally 3 DT01 tablets/day for 8 weeks
• DT01-Placebo tablets
Each subject was given orally 2 DT01 tablets and 1 Placebo tablet, three times per day for 8 weeks

Locations

Country	Name	City	State
Vietnam	Military Institute of Traditional Medicine	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Centre of Clinical Pharmacology, Hanoi Medical University

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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