Irritable Bowel Syndrome With Diarrhea
Conditions
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.
Interventions
DRUGDT01 tablets
Each subject was given orally 3 DT01 tablets/day for 8 weeks
DRUGPlacebo tablets
Each subject was given orally 3 DT01 tablets/day for 8 weeks
DRUGDT01-Placebo tablets
Each subject was given orally 2 DT01 tablets and 1 Placebo tablet, three times per day for 8 weeks
Sponsors
Centre of Clinical Pharmacology, Hanoi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal pain response | 8 weeks | 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 | 8 weeks | 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) | 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. |
Countries
Vietnam
Contacts
Primary ContactCentre of Clinical Pharmacology
Outcome results
None listed