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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Abdominal pain response
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo tablets
Posology: oral administration of 3 placebo tablets three times per day for 8 weeks.
干预措施: Placebo tablets (Drug)
DT01 tablets
Posology: oral administration of 3 DT01 tablets three times per day for 8 weeks.
干预措施: DT01 tablets (Drug)
DT01-Placebo tablets
Posology: oral administration of 2 DT01 tablets and 1 placebo tablet, three times per day for 8 weeks.
干预措施: DT01-Placebo tablets (Drug)
结局指标
主要结局
Abdominal pain response
时间窗: 8 weeks
Decrease in the weekly average of worst abdominal pain score in the past 24 hours of at least 30% 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)
时间窗: 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.
Stool consistency response
时间窗: 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.
次要结局
未报告次要终点