A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Pressure Pain Threshold
研究概览
简要总结
The investigators hypothesize that using Cyproheptadine in a placebo-controlled crossover trial would help relieve abdominal pain associated with (Functional Abdominal Pain (FAP) in children, achieving a greater response than that observed with placebo. In addition to assessing self-report of pain and other symptoms, the investigators also propose to perform experimental somatic pain testing to determine if there is evidence of peripherally-maintained central sensitization in children with FAP. The investigators also hypothesize that there will be an increase in somatic pain threshold after completion of a Cyproheptadine course compared to baseline testing prior to treatment, and compared to placebo. This would allow children with FAP to return to normal function, improve symptoms and overall general well-being
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
- 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
- •Age between 8 and 18 years-old
- •Diagnosed with Functional Abdominal Pain using the Rome III Criteria must include all* of the following:
- •Episodic or continuous abdominal pain
- •Insufficient criteria for other FGIDs
- •No evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the subject's symptoms
- •Criteria fulfilled at least once per week for at least 2 months prior to diagnosis
- •Written informed consent obtained from the patient/guardian before the initiation of any study-specific procedures
排除标准
- •Age < 8 years-old or Age >18 years-old
- •Child or parent are non-English speakers
- •Child is using other CNS depressants (cyproheptadine causes drowsiness, and may enhance the adverse/toxic effect of other CNS Depressants e.g. opioids, barbiturates, Droperidol, Hydroxyzine, Alcohol)(29)
- •Child has a history of hypersensitivity to Cyproheptadine products
- •Child is currently using monoamine oxidase inhibitor (MAOI e.g. Nardil, Marplan, Parnate) (can cause a prolonged or intensified anticholinergic effect)
- •Child was treated with Cyproheptadine in the past 4 weeks
- •Child is currently using anticholinergic (can cause an additive anticholinergic effect e.g. Pramlintide)
- •Concomitant SSRI use ( being a serotonin antagonist, may oppose effects)
- •Concomitant use of Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine
- •Concomitant use of Acetylcholinesterase Inhibitors (Central): Anticholinergics may diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central) and vice versa.
- •Child has a personal history of glaucoma
- •Child has asthma (can cause thickening of bronchial secretions) (27,28)
- •History of liver dysfunction/disease (can cause hepatitis)
- •History of cardiac disease (not specific to Cyproheptadine, antihistamines have been associated with hypotension, palpitations, tachycardia and arrhythmias) (28,29).
- •Females who are known to be pregnant will also be excluded. All females who are of child bearing age, or are already menstruating will perform a urine pregnancy test before enrolling.
- •Any children who have difficulties swallowing tablets will receive teaching on how to swallow tablets. If they are still unable to do so, they will not participate in the study.
研究组 & 干预措施
Cyproheptadine first then Placebo
4 weeks of cyproheptadine or placebo with crossover to the other
干预措施: Cyproheptadine (Drug)
Cyproheptadine first then Placebo
4 weeks of cyproheptadine or placebo with crossover to the other
干预措施: sugar pill (Drug)
Sugar Pill first then Cyprotheptadine
4 weeks of cyproheptadine or placebo with crossover to the other
干预措施: Cyproheptadine (Drug)
Sugar Pill first then Cyprotheptadine
4 weeks of cyproheptadine or placebo with crossover to the other
干预措施: sugar pill (Drug)
结局指标
主要结局
Pressure Pain Threshold
时间窗: at 4 weeks of cyproheptadine or placebo treatment
Increasing pressures were applied with a pressure plunger to the participants' thumbnail. The pressure at which the participant said that s/he felt pain is noted. The pressure is measured in kilograms by centimeters squared.
次要结局
- Abdominal Pain(10 weeks)
研究者
Ismaeel Hashemi
Fellow Physician
University of Michigan