NCT01076699暂停2 期
A Phase 2, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Four-Arm Trial to Evaluate the Safety and Efficacy of 3 Different Doses of RVX-100 Versus Placebo for the Treatment of Abdominal Pain in Patients With Irritable Bowel Syndrome Accompanied by Diarrhea (IBS-D)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Change in weekly average abdominal pain severity score from baseline.
研究概览
简要总结
The purpose of this study is to determine if RVX-100 is safe and effective in treating acute abdominal pain in patients with irritable bowel syndrome accompanied by diarrhea.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- •Positive for fecal ova and parasites (O&P) or Clostridium difficile (ELISA) or other bacterial pathogens (standard stool culture) during the Screening phase.
- •Taking medication for the treatment of IBS during the baseline phase (other than acetaminophen).
- •Taking any treatment for IBS including any of the following classes of medications within 2 weeks prior to baseline visit (Visit 2), or at any point during the study:
- •Antispasmodic or anticholinergic agents
- •Combination products including atropine, hyoscyamine, phenobarbital, and/or scopolamine
- •Antidepressants (such as monoamine oxidase inhibitors [MAOI], selective serotonin reuptake inhibitors [SSRIs], and tricyclic antidepressants), to include, but not limited to the following:
- •Combination products including pheniramine, phenyltoloxamine, or pyrilamine
- •Laxatives
- •Opioids/narcotic analgesics
- •Phenothiazines antipsychotics and anti-emetics
- •History of anticholinergic psychosis (psychosis associated with exposure to anticholinergic medications).
- •Laboratory values greater than three times the upper limit of normal (ULN) alanine transaminase (ALT/SGPT) or aspartate transaminase (AST/SGOT).
- •Laboratory values greater than two times the ULN for total bilirubin (TBil), creatinine (sCr) or blood urea nitrogen (BUN).
- •Active infection with hepatitis (A, B, or C) or positive confirmatory test for HIV1, or HIV2 (results of the HIV testing will be kept strictly confidential. Subject may wish to undergo HIV testing as per the guidelines for HIV testing requirements in India pursuant to NACO).
- •History of allergic reaction to l-hyoscyamine or atropine, or any component in the formulation of the study drugs.
- •Evidence of disease (based on medical history) that could adversely affect the subject's safety during participation in this study or interfere with the interpretation of study results, including but not limited to: glaucoma; pyloric stenosis; clinically significant benign prostatic hypertrophy; clinically significant heart or lung or disease; active peptic ulcer; celiac disease; digestive tract obstruction or paralysis; myasthenia gravis; inflammatory bowel disease; poorly controlled hypertension; hyperthyroidism; decreased hepatic or renal function; urinary retention, or lactose intolerance.
- •Use of any investigational drug within 30 days prior to the Baseline Visit (Visit 2), or anytime during study.
- •History of non-compliance with treatment or clinical visit attendance.
研究组 & 干预措施
placebo
Placebo Comparator
This group is taking a placebo
干预措施: placebo (Drug)
0.250 mg RVX-100
Active Comparator
This group is taking 0.250 mg RVX-100
干预措施: 0.250 mg RVX-100 (Drug)
Group taking 0.075 mg RVX-100
Active Comparator
This group is taking 0.075 mg RVX-100
干预措施: 0.075 mg RVX-100 (Drug)
Group taking 0.125 mg RVX-100
Active Comparator
This group is taking 0.125 mg RVX-100
干预措施: 0.125 mg RVX-100 (Drug)
结局指标
主要结局
Change in weekly average abdominal pain severity score from baseline.
时间窗: 4 weeks
次要结局
- Time to response, based on abdominal pain severity scores.(8 weeks)
- Number of pain-free days per week, based on responses to the Abdominal Pain Severity scale(8 weeks)
- Change in weekly average Abdominal Pain Severity score from baseline to week 8(8 weeks)
- Proportion of subjects in each treatment arm who are end-of-treatment responders(8 weeks)
- Proportion of subjects in each treatment arm who are weekly responders.(8 weeks)
- Bowel urgency(8 weeks)
- Stool consistency(8 weeks)
- Stool frequency(8 weeks)
- Fecal incontinence(8 weeks)
- Bloating(8 weeks)
研究者
研究点 (1)
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