Treatment of Diarrhea-Associated Fecal Incontinence With Eluxadoline
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Treatment Period 2 days per week with fecal incontinence
研究概览
简要总结
Accidental bowel leakage (fecal incontinence) increases in people who have diarrhea and sensations of urgency to have a bowel movement. Drugs such as loperamide (Imodium) that reduce diarrhea improve accidental bowel leakage, but loperamide has disadvantages: it is difficult to find a dose that does not cause constipation, and it does not reduce urge sensations. Eluxadoline is a new drug that is effective for reducing diarrhea, abdominal pain, and urgency in patients with irritable bowel syndrome, and it may be less likely than loperamide to cause severe constipation. Therefore, eluxadoline may help patients manage accidental bowel leakage caused by diarrhea. The chemical name for Viberzi® is eluxadoline.
The primary aims of this study are to find out if eluxadoline at a dose of 100 mg orally twice a day will reduce the average number of days the patient has accidental bowel leakage, and to see if the rate of accidental bowel leakage increases when the patient stops taking eluxadoline. Additional goals are to find out if eluxadoline decreases diarrhea and urge sensations.
This is a small (pilot) study to show whether eluxadoline is an effective way of treating accidental bowel leakage. If the study shows this, a larger study will be needed. There are three phases to this 12-week study: (1) A two-week run-in period to see if the patient meets the inclusion criteria. (2) Two months for treatment including one month on eluxadoline and one on placebo (sugar pills) twice a day. (3) A two-week follow-up to see what happens when you stop taking eluxadoline.
To participate in the study, patients should be aged 18 or older. Patients with inflammatory bowel disease, anal fissures, or congenital malformations will be excluded.
The primary outcome is the average number of days per week with any solid or liquid bowel accidents. Additional information includes: (1) Number of days per week the patient takes loperamide, (2) days per week with loose or watery stools, (3) days per week with moderate to strong urge sensations, and (4) questionnaires to measure the severity of accidental bowel leakage, quality of life, anxiety, and depression. There will be up to 38 patients in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Patients will not be aware when Eluxadoline or Placebo are administered. Investigators will be masked to whether Eluxadoline is given in Treatment Period 1 or Treatment Period 2 unless there is an adverse event that requires unmasking the treatment for this patient to ascertain whether the adverse event is drug-related.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age.
- •Any gender, race, or ethnicity.
- •Must self-report an average of at least 2 episodes of solid or liquid FI per week for the previous month.
- •Must self-report an average of at least 2 bowel movements (BMs) per week that are Bristol Types 6 or 7 (mushy or liquid stools).
- •Subjects must have access to the internet at home and be willing to enter symptom data each night before sleeping.
排除标准
- •Patients with inflammatory bowel disease, anal fissure, or congenital malformations as a cause of FI will be excluded.
- •Subjects who start the study and do not experience at least 4 episodes of solid or liquid FI and at least 4 BMs that are Bristol Stool types 6 or 7 during the first two weeks will be withdrawn from the study.
- •Subjects who do not provide at least 4 days of valid stool diary data per week during the first two weeks will be withdrawn from the study.
研究组 & 干预措施
Eluxadoline followed by Placebo
Following a 2-week run-in period, patients will receive Eluxadoline 100 mg twice daily for 4 weeks then placebo tablets taken twice daily for 4 weeks followed by a 2-week follow-up period during which placebo will be administered twice daily.
干预措施: Eluxadoline 100 mg (Drug)
Eluxadoline followed by Placebo
Following a 2-week run-in period, patients will receive Eluxadoline 100 mg twice daily for 4 weeks then placebo tablets taken twice daily for 4 weeks followed by a 2-week follow-up period during which placebo will be administered twice daily.
干预措施: Placebo (Other)
Placebo followed by Eluxadoline
Following a 2-week run-in period, patients will receive placebo twice daily for 4 weeks then Eluxadoline 100 mg twice daily for 4 weeks followed by a 2-week follow-up period during which placebo will be administered twice daily.
干预措施: Eluxadoline 100 mg (Drug)
Placebo followed by Eluxadoline
Following a 2-week run-in period, patients will receive placebo twice daily for 4 weeks then Eluxadoline 100 mg twice daily for 4 weeks followed by a 2-week follow-up period during which placebo will be administered twice daily.
干预措施: Placebo (Other)
结局指标
主要结局
Treatment Period 2 days per week with fecal incontinence
时间窗: Treatment Period 2 (measured across Weeks 9 and 10)
If there are less than 5 days in a 7-day period that have complete diary data in weeks 9 and 10, the Treatment Period 2 variable is missing. The number of days per week with fecal incontinence (i.e., a score \>0) will be counted and divided by 7 to obtain a rate per week. The range of scores is 0 to 7 with 7 being the most severe fecal incontinence.
Follow-up days per week with fecal incontinence
时间窗: Follow-up period (measured across Weeks 11 and 12)
If there are less than 5 days in a 7-day period that have complete diary data in weeks 11 and 12, the Follow-Up variable is missing. The number of days per week with fecal incontinence (i.e., a score \>0) will be counted and divided by 7 to obtain a rate per week. The range of scores is 0 to 7 with 7 being the most severe fecal incontinence.
Run-in days per week with fecal incontinence
时间窗: Baseline Period, starting on Day 1 and ending at the conclusion of Day 14
If there are less than 5 days in a 7-day period that have complete diary data, the subject will be excluded. The number of days per week with fecal incontinence (i.e., a score \>0) will be counted and divided by 7 to obtain a rate per week. The range of scores is 0 to 7 with 7 being the most severe fecal incontinence.
Treatment Period 1 days per week with fecal incontinence
时间窗: Treatment Period 1 (measured across Weeks 5 and 6)
If there are less than 5 days in a 7-day period that have complete diary data in weeks 5 and 6, the Treatment Period 1 variable will be missing. The number of days per week with fecal incontinence (i.e., a score \>0) will be counted and divided by 7 to obtain a rate per week. The range of scores is 0 to 7 with 7 being the most severe fecal incontinence.
次要结局
- Fecal Incontinence Severity Score (FISS) over time(Weeks 2, 6,10, and 12)
- Fecal Incontinence Quality of Life Scale Score for Lifestyle (FIQOL-Lifestyle)(Weeks 2, 6, 10, and12)
- Fecal Incontinence Quality of Life Scale Score for Coping/Behavior (FIQOL-Coping/Behavior)(Weeks 2, 6, 10, and 12)
- Preference for study drug vs. loperamide(Weeks 6, and 10)
- Fecal Incontinence Quality of Life Scale Score for Depression/Self-Perception (FIQOL-Depression/Self-Perception)(Weeks 2, 6, 10, and 12)
- Preference for eluxadoline or placebo(Week 10)
- Days per week with loperamide (escape medication)(Weeks 1, 2, 5, 6, 9, 10, 11, and 12)
- Days per week patient described bowel movements as 6 or 7 on the Bristol Stool Scale(Weeks 1, 2, 5, 6, 9, 10, 11, and 12)
- Days per week patient reported strong urge sensations(Weeks 1, 2, 5, 6, 9, 10, 11, and 12)
- Fecal Incontinence Quality of Life Scale Score for Embarrassment (FIQOL-Embarrassment)(Weeks 2, 6, 10, and 12)
- Brief Symptom Inventory-18 Anxiety Score (BSI-Anxiety)(Weeks 2, 6, 10, and 12)
- Brief Symptom Inventory-18 Depression Score (BSI-Depression)(Weeks 2, 6, 10, and 12)