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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre of Clinical Pharmacology, Hanoi Medical University

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:

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.