Effect of Rozerem on the Perception of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Chronic Insomnia.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology.
研究概览
简要总结
To determine if administration of Rozerem in comparison to a placebo reduces or eliminates gastroesophageal reflux disease(GERD) symptoms in individuals with both GERD and chronic insomnia.
详细描述
This is a prospective, randomized, double-blind parallel group study comparing the effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology as the primary outcome, and sleep quality and quality of life as secondary outcomes.
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
- — 至 82 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stop H2 blockers 72 hrs prior to starting study
- •Stop PPI - 3 weeks prior to staring study
- •Heartburn 3+ times a week
- •Insomnia 3+ times a week for 3 months
- •Erosive esophagitis or Abnormal pH test
排除标准
- •On PPI or H2 blocker & not willing to get off
- •Normal EGD (upper endoscopy) w/ normal pH test
- •Upper Endoscopy(EGD)with erosive esophagitis(EE)- (LA C&D) LA=Los Angeles criteria. Grades include A-D
- •Previous gastrointestinal Surgery
- •HX of Diabetes/neuropathy
- •HX of seizures
- •Known psychological abnormalities(depression,anxiety...)
- •Clinically Significant Underlying co morbidity
- •Narcotic medications(pain meds)
- •Regularly taking sleeping medications (2 week wash-out allowed)
- •Taking medications that alter sleep-Psychotropic's, antihistamines, Narcotics and Benzodiazepines Sleep Apnea or other sleep disorders-PLM, RLS etc.
研究组 & 干预措施
Rozerem
Comparing the effect of Rozerem vs. placebo on GERD symptomatology.
干预措施: Rozerem (ramelteon) (Drug)
placebo
Comparing the effect of Rozerem vs. placebo on GERD symptomatology
干预措施: placebo (Drug)
结局指标
主要结局
The effect of Rozerem vs. placebo on gastroesophageal reflux disease(GERD) symptomatology.
时间窗: 4 week trial
The effect of Rozerem vs. placebo on GERD symptomatology as the primary outcome, and sleep quality and quality of life as secondary outcomes.
次要结局
- Improving quality of sleep and quality of life.(4 week trial period)