NCT01269671撤回1 期
Efficacy of Combination Therapy vs Placebo for Pediatric Functional Abdominal Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Anxiety Affects
研究概览
简要总结
IND application was submitted to FDA on November 17th.
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
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To participate in this study, the child/teen must be a patient of the FAP Clinic/GI Clinic in the Division of Gastroenterology at the Children's Hospital of Wisconsin, and have a parent or legal guardian who is willing to participate. Children aged 8-18 years will be eligible for inclusion in the study.
排除标准
- •Children or parents who are non-English speaking, or parents and/or children with cognitive delay that precludes comprehension and completion of questionnaires will be excluded from participating in this registry.
研究组 & 干预措施
Melatonin, Peppermint Oil, Simethicone
Experimental
干预措施: Melatonin, Peppermint Oil (mentharil), and Simethicone (Drug)
Sugar pill
Placebo Comparator
干预措施: Sugar pill (Other)
结局指标
主要结局
Anxiety Affects
时间窗: 8 weeks
To determine if patient anxiety affects treatment outcomes in patients with functional bowel disorders.
Quality of Life
时间窗: 8 weeks
To evaluate improvement in quality of life in children treated with combination therapy versus placebo.
Pain Reduction
时间窗: 8 weeks
To evaluate the efficacy of the treatment combination of Melatonin, Peppermint Oil, and Simethicone in releiving the symptoms of pain in Irritable Bowel Syndrome, Functional Abdominal Pain, and Functional Dyspepsia compared to treatment outcomes to placebo.
次要结局
未报告次要终点
研究者
研究点 (1)
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