A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,146
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores
研究概览
简要总结
The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of eluxadoline (JNJ-27018966) compared with placebo in the treatment of participants with diarrhea-predominant irritable bowel syndrome.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is 18 to 80 years old
- •Participant has a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea defined by the Rome III criteria.
- •Participant has had a colonoscopy performed:
- •Within 10 years prior to Prescreening if participant is at least 50 years of age (sigmoidoscopy, double contrast barium enema, or computed tomography (CT) colonography within the past 5 years is acceptable)
- •Since the onset (if applicable) of any of the following alarm features for participants of any age
- •Participant has documented weight loss within the past 6 months
- •Participant has nocturnal symptoms
- •Participant has a familial history of first-degree relatives with colon cancer
- •Participant has blood mixed with their stool (excluding blood from hemorrhoids).
- •Female participants must be:
- •Postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at Prescreening,
- •Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
- •Abstinent, or
- •If sexually active, be practicing an effective method of birth control.
排除标准
- •Participant has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria.
- •Participant has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease.
- •Participant has a history of diverticulitis within 3 months prior to Prescreening.
- •Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).
- •Participant has any of the following surgical history:
- •Cholecystectomy with any history of post cholecystectomy biliary tract pain
- •Any abdominal surgery within the 3 months prior to Prescreening
- •Participant has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed)
- •Other protocol-specific eligibility criteria may apply.
研究组 & 干预措施
Eluxadoline 75 mg
Eluxadoline 75 mg tablets, orally, twice daily for up to 26 weeks period.
干预措施: Eluxadoline (Drug)
Eluxadoline 100 mg
Eluxadoline 100 mg tablets, orally, twice daily for up to 26 weeks period.
干预措施: Eluxadoline (Drug)
Placebo
Eluxadoline placebo matching tablets, orally, twice daily for up to 26 weeks period.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores
时间窗: Up to 12 weeks
Composite responders were defined as participants who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score \<5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.
次要结局
- Number of Bowel Incontinence Free Days(Weeks 4, 12 and 26)
- Number of Urgency Episodes Per Day(Weeks 4, 12 and 26)
- Change From Baseline in Daily Abdominal Bloating Scores(Baseline, Weeks 4, 12 and 26)
- Number of Bowel Movements Per Day(Weeks 4, 12 and 26)
- Number of Bowel Incontinence Episodes(Weeks 4, 12 and 26)
- Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores(Up to 26 weeks)
- Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals(12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24))
- Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals(12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24))
- Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale(Weeks 4, 8, 12, 18, 26 and 30 (End of Treatment [EOT]))
- Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale(12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26))
- Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals(12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24))
- Change From Baseline in Daily Abdominal Discomfort Scores(Baseline, Weeks 4, 12 and 26)
- Change From Baseline in IBS-QoL Total Scores(Baseline, Weeks 4, 8, 12, 18, 26 and 30/EOT)