NCT01214408已完成4 期
Effect of Digene Total on 24 Hrs Ambulatory Gastric ph in Pts Suffering From Acid Peptic Disorder After Single and Repeated Dosing.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Time taken to achieve a gastric pH of > 4 after a single dose of Digene Total (buffered pantoprazole)
研究概览
简要总结
This prospective, open label, single-center and non-comparative study is designed to generate data on Digene Total's (buffered pantoprazole) rapid and sustained gastric acid inhibition effect in patients suffering from acid peptic disorders.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (18-65 years) suffering from acid peptic disorder (APD), diagnosed endoscopically (reflux esophagitis, gastritis and peptic ulcer)
- •Must voluntarily sign and date an informed consent form, approved by an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to any study specific procedures.
- •If female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control:
- •Total abstinence from sexual intercourse (minimum one completed menstrual cycle)
- •A vasectomized partner
- •Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration.
- •Intrauterine device (IUD)
- •Double barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or creams)
排除标准
- •Subjects with concurrent gastrointestinal diseases, gastric surgery, perforation or bleeding
- •Subjects who have a history of use of any antisecretory drug within past 7 days prior study Day 0
- •Subjects with cardiac, neurological, renal or hepatic dysfunction
- •Past history of significant sensitivity or contraindication to study drug
- •Pregnant or breast-feeding female
- •Any condition that, in the opinion of the Investigator, does not justify the subject's inclusion for the study
研究组 & 干预措施
GRP-A
Experimental
干预措施: Buffered pantoprazole (Drug)
GRP-B
Experimental
干预措施: Buffered pantoprazole (Drug)
结局指标
主要结局
Time taken to achieve a gastric pH of > 4 after a single dose of Digene Total (buffered pantoprazole)
时间窗: Assessment done on day 1 for group A subjects
次要结局
- Percentage of time gastric pH was > 4 after repeated dosing of Digene Total (buffered pantoprazole)(Assessment done on day 7 for all subjects)
- 24 hour median gastric pH after repeated dosing of Digene Total (buffered pantoprazole)(Assessment done on day 1 for group A subjects)
研究者
研究点 (1)
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