Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Symptom control
研究概览
简要总结
Despite the use of proton pump inhibitors and available prokinetics, medical therapy is ineffective in an important number of children with cerbreal palsy (CP) and gastroesophageal reflux disease (GERD), and failure of medical therapy is associated with a substantial morbidity. Many patients, particularly children with CP and GERD, continue to experience complications despite aggressive therapy because antisecretory medications do not address the primary reflux mechanism (TLESR). Furthermore, in patients with CP, surgical options are fraught with serious complications and long-term morbidity. Because the available treatment options for children with CP and intractable GERD are limited, new therapies are urgently needed. Baclofen, which has been shown in animals and humans to decrease TLESRs, may be a good alternative for the treatment of children with CP with intractable GERD.
详细描述
Despite the use of proton pump inhibitors and available prokinetics, medical therapy is ineffective in an important number of children with cerbreal palsy (CP) and gastroesophageal reflux disease (GERD), and failure of medical therapy is associated with a substantial morbidity. Many patients, particularly children with CP and GERD, continue to experience complications despite aggressive therapy because antisecretory medications do not address the primary reflux mechanism (TLESR).
This is a placebo controlled trial of baclofen for the treatment of GERD in children with CP.
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3-18 years old
- •Diagnosis of Cerebral Palsy
- •Symptoms of GERD for at least 3 months
- •At least 8 weeks on BID therapy with a PPI at a therapeutic dose at time of enrollment
- •Normal upper gastrointestinal barium contrast study (UGI)
- •Have a g-tube that is used for more than 75% of calories and a stable feeding schedule for at least 2 weeks
- •If seizures are present, they need to be controlled and on stable medications for 4 weeks
排除标准
- •Underlying electrolyte disturbance
- •History of Nissen fundoplication
- •Renal insufficiency
- •Currently receiving baclofen
- •Baclofen allergy
- •Uncontrolled seizure disorder
- •Lack of informed consent
研究组 & 干预措施
baclofen
Baclofen suspension
干预措施: Baclofen (Drug)
placebo
Identical palcebo suspension
干预措施: placebo (Drug)
结局指标
主要结局
Symptom control
时间窗: 3 weeks
Symptom frequency during the 2 weeks of placebo and baclofen administration.
次要结局
- GERD control(3 weeks)
- side effects of baclofen(3 weeks)
研究者
Samuel Nurko
Attending Physician; Director, Center for Motility and Functional Gastrointestinal Disorders
Boston Children's Hospital