A Placebo Controlled Study of Colesevelam in Fecal Incontinence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Number of Participants to Report a 50% or Greater Reduction in Weekly Fecal Incontinence (FI) Episodes
研究概览
简要总结
Compare the effects of a combination of colesevelam and clonidine to placebo on bowel symptoms in patients with urge or combined type of FI.
详细描述
Fecal incontinence (FI) is a common symptom that can significantly impair quality of life. There is very limited, mostly uncontrolled, evidence to support the approaches currently used to manage FI. The alpha-2 adrenergic agonist clonidine decreased the frequency of loose stools in FI patients with diarrhea. Among patients with diarrhea, clonidine decreased the proportion of days with FI; however results were not statistically significant. Uncontrolled studies suggest that the bile acid binding resin colesevelam also increased stool consistency in patients with functional diarrhea. In this study, the investigators propose to compare the effects of a combination of colesevelam and clonidine to placebo on bowel symptoms in patients with urge or combined type of FI.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •i) Females aged 18-80 years with urge predominant or combined (i.e. urge plus passive) FI, as defined by a validated questionnaire, for at least 1 year duration will be eligible to participate.
排除标准
- •(i) History of clinically serious cardiovascular or pulmonary disease or EKG showing 2nd degree atrioventricular block or higher.
- •(ii) Current or past history of rectal cancer, scleroderma, inflammatory bowel disease, small bowel obstruction, congenital anorectal abnormalities, Grade 2 rectal prolapse, history of rectal resection or pelvic irradiation (iii) Neurological disorders - Spinal cord injuries, dementia (Mini-Mental status score <21), multiple sclerosis, Parkinson's disease, peripheral neuropathy (iv) Conditions precluding safe use of clonidine, i.e., symptomatic hypotension, or systolic blood pressure of <100 mm Hg on initial visit in Phase 1 of study (v) Currently pregnant or nursing women (vi) Prior history of intolerance to clonidine or colesevelam (vii) Medications Absolute - opioid analgesics. Relative - other antihypertensive agents (i.e. if there is concern about synergistic effects and hypotension). Patients using drugs with anticholinergic effects will be excluded if they are used at high doses (e.g. nortriptyline greater than 50 mg/day or amitriptyline greater than 25 mg/day). Patients who use lower doses will be eligible to participate provided the dose will be stable during the study
- •Inclusion Criteria:
- •i) Females aged 18-80 years with urge predominant or combined (i.e. urge plus passive) FI for at least 1 year, as defined by questionnaire
- •Exclusion criteria:
- •(i) Positive urine pregnancy screen
- •Inclusion criteria:
- •(i) Completion of at least 5 out of 7 days of the diary in the preceding week and 10 out of 14 in the preceding 2 weeks (ii) At least 1 episode of FI per week averaged over 2 weeks (iii) Average Bristol stool score of 3 or higher (iv) Average stool frequency of ≥1/day
- •Exclusion criteria (if at least one is satisfied):
- •(i) Missing data in bowel diaries, i.e. if patient did not record bowel symptoms data for more than 2 days in 1 week or 4 days over 2 weeks (ii) Greater than 6 liquid [Bristol 6 or 7]) stools daily (iii) Average of less than 1 bowel movement daily (iv) Average Bristol stool score <3 as assessed from analysis of bowel diaries
- •Inclusion criteria:
- •(i) All patients who complete at least 1 week of treatment with study drugs or placebo
- •Exclusion criteria:
- •(i) Patients who completed less than 1 week of treatment with study drugs or placebo
研究组 & 干预措施
Placebo
Participants in this arm will receive placebo for 4 weeks.
干预措施: Placebo (Other)
Colesevelam and Clonidine
Participants in this arm will receive a combination of colesevelam (1.875 gm twice daily) and clonidine (0.1 mg oral twice daily) for 4 weeks.
干预措施: Colesevelam (Drug)
Colesevelam and Clonidine
Participants in this arm will receive a combination of colesevelam (1.875 gm twice daily) and clonidine (0.1 mg oral twice daily) for 4 weeks.
干预措施: Clonidine (Drug)
结局指标
主要结局
Number of Participants to Report a 50% or Greater Reduction in Weekly Fecal Incontinence (FI) Episodes
时间窗: 4 weeks
The number of participants that report a 50% or greater reduction in weekly incontinent episodes as measured by self-reported bowel diaries.
次要结局
- Daily Stool Frequency(4 weeks)
- Stool Consistency(4 weeks)
- Number of Semi-Formed Stools Per Week(4 weeks)
- Delay of Bowel Movement(4 weeks)
- Total Fecal Incontinence Episodes(4 weeks)
- Volume of Fecal Incontinence(4 weeks)
- Percent of Incontinent Bowel Movements Pre-treatment(baseline)
- Percent of Incontinent Bowel Movements During Treatment(4 weeks)
- Percent of Incontinent Bowel Movements to be Semi-Formed Stools Pre-Treatment(baseline)
- Percent of Incontinent Bowel Movements to be Semi-Formed Stools During Treatment(4 weeks)
- Severity of Bowel Symptoms(4 weeks)
- Severity of Fecal Incontinence(4 weeks)
- Fecal Incontinence Quality of Life (FI-QoL)(4 weeks)
- Loperamide Tablets Per Week(4 weeks)