A Phase 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 451
- 主要终点
- Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.
研究概览
简要总结
The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).
详细描述
This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo, in maintaining healing of erosive esophagitis.
Because the development plan for Dexlansoprazole MR formulation was revised, the results of 2 identical studies, T-EE04-086 (this study, NCT00255164) and T-EE04-087 (NCT00255151), were combined and analyzed as a single larger study referred to as study T-EE04-086. A total of 451 subjects were included in the combined analysis: 237 subjects were enrolled into Study T-EE04-086, and 214 subjects were enrolled into Study T-EE04-087.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or TEE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy. Complete healing was assessed for change in LA Esophagitis Classification grades A, B, C, or D to healed (defined as anything less than the criterion for Grade A). The subject was counted as healed if endoscopy findings did not meet the Grade A criterion.
排除标准
- •Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study
- •Use of antacids (except for study supplied) throughout the study.
- •Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.
- •Need for continuous anticoagulant therapy.
研究组 & 干预措施
Dexlansoprazole MR 60 mg QD
干预措施: Dexlansoprazole MR (Drug)
Dexlansoprazole MR 90 mg QD
干预措施: Dexlansoprazole MR (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.
时间窗: 6 months
Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method
时间窗: 6 months
Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.
次要结局
- Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.(6 months)
- Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.(6 months)
- Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.(6 months)
- Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.(6 months)