Assessment of the Effects of Zegerid Powder for Oral Suspension 40 mg on 24-Hour and Nocturnal Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease and Barrett's Esophagus
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Percentage of Time Esophageal pH< 4
研究概览
简要总结
The purpose of this research study is to assess how safe, effective (how well it works), and tolerable (to put up with) the drug Zegerid is in reducing reflux episodes in patients who have both gastroesophageal reflux disease (GERD) and Barrett's esophagus. Zegerid has been approved by the US Food and Drug Administration (FDA) for the treatment of GERD. The investigators hope to learn the effectiveness of Zegerid for reducing the amount of acid reflux patients are experiencing in the esophagus (swallowing pipe).
详细描述
The following procedures will be performed at the Screening Visit:
- Obtain informed consent.
- Obtain information about your age and gender.
- Evaluate whether you qualify for the study.
- Document prior negative testing for H. pylori infection (a bacterial infection in the stomach that can cause ulcers) including the date of testing.
- Make sure that you have not used any investigational medications or participated in a clinical trial in the 30 days prior to the Screening Visit.
- Obtain medical history.
- Record medication history (including concomitant medications).
- Obtain vital signs.
- Conduct a physical examination.
- If a Bravo pH study has not been done within 8 weeks, instruct the patient to discontinue their medication for GERD during the 7-10 day washout period.
- Instruct the patient to discontinue the use of all prohibited medications during the applicable time intervals and not to start any new concomitant medications during the trial.
- Distribute Gelusil tablets to be used as "rescue medication"; instruct the patient that no more than 6 Gelusil tablets per day or 21 tablets over any 7-day interval will be allowed.
- Schedule the patient to return for the Qualification Visit, or for pH monitoring and the Qualification Visit. Only patients with abnormal pH monitoring will be able to enter the treatment period.
Procedures that will occur during the Treatment Period:
- You will receive Zegerid 1 hour before breakfast and at bedtime for at least 14 days and no longer than 28 days
- At the end of the Zegerid treatment period, you will undergo 48-hour Bravo pH monitoring on Zegerid therapy for two days. You will complete a symptom survey and quality of life survey after the completion of the pH study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria include adult men and women (aged <=18 years) with previously established, biopsy-proven diagnosis of BE (any length intestinal metaplasia without dysplasia or adenocarcinoma)
排除标准
- •Exclusion criteria include a history of esophageal, gastric, or duodenal surgery (including antireflux surgery or endoscopic antireflux procedures), except for simple ulcer closure
- •Zollinger-Ellison syndrome
- •Endoscopic evidence or suspicion of a pathologic or infiltrative process in the stomach
- •Positive for H. pylori.
研究组 & 干预措施
Received Zegerid (Ome-NaBic)
Administered Ome-NaBic 40 mg orally 1 h before breakfast and bedtime
干预措施: Zegerid (proton pump inhibitor) (Drug)
Received Zegerid (Ome-NaBic)
Administered Ome-NaBic 40 mg orally 1 h before breakfast and bedtime
干预措施: Bravo pH monitoring (Procedure)
结局指标
主要结局
Percentage of Time Esophageal pH< 4
时间窗: Days 1 and 2
Reported as the the average percentage over 24 hours of total time, upright time, and supine time per day with pH \<4 (symptomatic acid state) as evaluated with the Bravo pH monitoring technique.
次要结局
- Reflux Disease Questionnaire Score on Day 1 After Therapy Completion(Day 1 after therapy period completion)