NCT03806127已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 40
- 主要终点
- Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12
研究概览
简要总结
This study will evaluate the efficacy and safety of vibegron, a beta-3 adrenergic receptor (β3-AR) agonist, in the treatment of pain associated with irritable bowel syndrome (IBS) due to IBS with predominant diarrhea (IBS-D) or mixed episodes of diarrhea and constipation (IBS-M).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of irritable bowel syndrome (IBS) with predominantly diarrhea (IBS-D) or IBS with mixed episodes of diarrhea and constipation (IBS-M) according to the Rome IV criteria
- •Has completed a colonoscopy according to the American Gastroenterological Association criteria, with no clinically significant findings in the last 5 years
- •Has no clinically significant findings on a physical examination or clinical laboratory tests that could interfere with study participation or confound study assessments, in the opinion of the Investigator. Serum tissue transglutaminase antibody (IgA) must be negative. Fecal calprotectin testing is optional and should only be considered if there is a strong suspicion that the participant has inflammatory bowel disease (IBD) (eg, family history in a 1st degree relative, other genetic factors, etc.) or other organic disease, according to the clinical judgement of the investigator.
排除标准
- •Diagnosis of IBS-C or IBS-U per Rome IV criteria
- •History of chronic idiopathic constipation or functional constipation
- •Structural abnormality of the gastrointestinal tract or a disease (e.g., known small intestine bacterial overgrowth) or condition that can affect gastrointestinal motility
- •History of a gastrointestinal motility disorder other than IBS (e.g., gastroparesis, intestinal pseudo-obstruction, achalasia, Parkinsons disease, multiple sclerosis, spinal cord injury)
- •Prior history of a gastrointestinal malignancy, inflammatory bowel disease, celiac disease
- •Planned gastrointestinal or abdominal surgery within the next 6 months
- •Co-existing gastroesophageal reflux disease or functional dyspepsia with symptoms predominant to IBS symptoms
- •Symptoms or diagnosis of a medical condition other than IBS that may contribute to abdominal pain (e.g., interstitial cystitis; fibromyalgia currently being treated with pregabalin or gabapentin; and endometriosis with uncontrolled abdominal pain)
研究组 & 干预措施
Vibegron 75 mg
Experimental
Participants will receive vibegron 75 milligrams (mg) orally once daily for 12 weeks.
干预措施: Vibegron (Drug)
Placebo
Placebo Comparator
Participants will receive matching placebo orally once daily for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Irritable Bowel Syndrome (IBS) With Predominantly Diarrhea (IBS-D) Participants Who Were Abdominal Pain Intensity (API) Weekly Responders at Week 12
时间窗: Baseline; Week 12
An API Weekly Responder was defined as a participant who experienced a decrease in the weekly average of "worst abdominal pain in the past 24 hours" scores of at least 30% compared with the Baseline weekly average. A participant was considered a responder over Weeks 1 to 12 if they met the criteria for at least 50% of the weeks assessed (i.e., ≥6 weeks).
次要结局
- Number of IBS-D Participants Who Were API Weekly Responders With ≥ 40% Improvement Over 12 Weeks(Baseline; 12 weeks)
- Number of IBS-D Participants Who Were API Weekly Responders With ≥ 50% Improvement Over 12 Weeks(Baseline; 12 weeks)
- Number of Global Improvement Scale (GIS) Responders at Week 12 for All IBS Participants, Including IBS-D and IBS-M Participants(Week 12)
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(from the time the participant provided informed consent to participate in the study at the Screening Visit until completion of the Safety Follow-up Call (up to Day 113 or Early Withdrawal plus 28 days))
- Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Laboratory Values at Week 12(Baseline; Week 12)
- Number of Participants With Clinically Relevant Changes From Baseline in Vital Sign Values at Week 12(Baseline; Week 12)
研究者
研究点 (40)
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