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临床试验/NCT00539240
NCT00539240已完成2 期

Role of Pain Modulation in GERD Patients Who Failed Standard Dose PPI

US Department of Veterans Affairs1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2006年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
236
试验地点
1
主要终点
Daytime Heartburn, Number of Days in Week Symptoms Intensity Score < 3 (Better)

研究概览

简要总结

The purpose of this project is to compare the efficacy (how successful) 1) standard-dose proton pump inhibitor (PPI) (rabeprazole 20 mg once daily) (a medication that completely blocks the stomach from producing acid) plus low dose tricyclic antidepressant (nortriptyline 50mg) (TCA); 2) double-dose PPI (rabeprazole 20 mg twice a day); to 3) standard-dose PPI (rabeprazole 20mg once daily) and placebo (an inactive substance, like a sugar pill) to determine the relative symptom resolution and health-related quality of life in gastroesophageal reflux disease (a disease characterized by a burning sensation (heartburn) behind the breast bone caused by a backflow of stomach contents into the esophagus) (GERD) patients who fail standard-dose PPI and you will be randomly assigned (similar to flipping a coin) to one of the three groups.

详细描述

Failure of standard dose PPI to control GERD symptoms has been increasingly encountered in clinical practice (both primary care and sub-specialties) and has become one of the most challenging therapeutic dilemmas in GERD management. It has been estimated that up to 30% of the patients receiving PPI once daily will continue to report typical GERD symptoms [1]. Presently, increasing the PPI dose has been the standard of care in these patients [2]. However, success in relieving refractory GERD symptoms with such a therapeutic approach has been extremely limited, resulting in frustration of both the patient as well as the health care provided. Furthermore, patients who fail PPI will continue to seek medical attention and may undergo a variety of invasive or non-invasive tests, and thus consume already limited health care resources. Recent advancement in the understanding of the diverse composition of the different GERD groups as well as symptom generation has led to the recognition of alteration in pain perception as an important contributing factor for PPI failure in some and the presence of non-acid related stimuli in others [3].

This study will clarify for the first time the role of pain modulation in patients who failed standard dose of PPI. The clinical experience with doubling the PPI dose, which is the current standard of care, has been very limited and relatively disappointing. Additionally, this study may identify the group of PPI failure patients that may benefit from doubling the dose of PPI and the group that will benefit more from adding a pain modulator. This study is timely, has never been performed and addresses a prevalent emerging clinical dilemma in GI as well as primary care clinics.

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
Double

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Currently being treated with a PPI, but continue to experience GERD symptoms (such as heartburn) at least 2 times per week.

排除标准

  • Known allergy or intolerance to TCA
  • History of serious arrhythmia or use of anti-arrhythmics
  • History of seizures
  • Subjects with significant co-morbidity, e.g., cardiovascular, respiratory, urogenital, renal, gastrointestinal, hepatic, hematological, endocrine, neurologic or psychiatric
  • With evidence or history of drug abuse within the past 6 months
  • Erosive esophagitis, esophageal ulceration, peptic stricture, Barrett's esophagus or adenocarcinoma of the esophagus on endoscopy
  • History of esophagogastric surgery
  • Gastric or duodenal lesions (ulcer, tumor, etc.)
  • Women who are pregnant or of childbearing age who are not on contraception
  • Patients who are unwilling or unable to provide informed consent
  • Insulin dependent diabetes

研究组 & 干预措施

Rabeprazole morning/evening placebo bedtime

Placebo Comparator

AciPhex 20 mg BID and once daily placebo

干预措施: Rabeprazole 20 mg two times, Placebo at bedtime (Drug)

Rabeprazole breakfast, placebo dinner and bedtime

Placebo Comparator

AcipHex 20 mg once daily and BID placebo

干预措施: Rabeprazole 20mg, placebo dinner and bedtime (Drug)

Rabeprazole breakfast, placebo dinner, nortriptyline bedtime

Active Comparator

AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily

干预措施: Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant (Drug)

结局指标

主要结局

Daytime Heartburn, Number of Days in Week Symptoms Intensity Score < 3 (Better)

时间窗: Symptom control after 6 weeks of treatment

the number of days with Symptom Intensity Score \< 3 (better) for daytime heartburn during week 6 as compared to baseline

Acid Regurgitation, Number of Days in Week Symptoms Intensity Score < 3 (Better)

时间窗: Symptom control after 6 weeks of treatment

the number of days with Symptom Intensity Score \< 3 (better) for acid regurgitation during week 6 as compared to baseline

Nighttime Heartburn, Number of Days in Week Symptom Activity Score <3 (Better) in Week 6 Compared to Baseline

时间窗: Symptom control after 6 weeks of treatment

the number of days with Symptom Intensity Score \< 3 (better) for nighttime heartburn during week 6 as compared to baseline

次要结局

  • Health Related Quality of Life(end of study)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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