A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (60 mg Once-Daily (QD) and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 908
- 主要终点
- Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily [QD]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (GERD).
详细描述
This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate symptom relief in subjects with symptomatic non-erosive GERD. Approximately 450 subjects will be enrolled at approximately 120 U.S. and potentially ex U.S. sites. The study consists of two periods; a screening period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks.
Because the development plan for Dexlansoprazole MR was revised, the results of 2 identical studies, T-GD04-082 (this posting, NCT00241745) and T-GD04-083 (NCT00251758), were combined and analyzed as a single larger study referred to as study T-GD04-082. A total of 908 subjects were included in the combined analysis; 416 subjects were enrolled into Study T-GD04-082 and 492 subjects were enrolled into Study T-GD04-083.
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 with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn.
- •History of episodes of heartburn for 6 months or longer prior to screening.
- •History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary.
排除标准
- •Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study·
- •Use of antacids (except for study supplied Gelusil®).
- •Use of drugs with significant anticholinergic effects.
- •Need for continuous anticoagulant (blood thinner) therapy.
- •Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus.
- •History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter).
- •Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition.
- •History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer.
- •Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the screening endoscopy.
- •Erosive Esophagitis seen on endoscopy during study screening.
- •Co-existing diseases affecting the esophagus.
- •Abnormal laboratory values that suggest significant clinical disease.
- •Known acquired immunodeficiency syndrome (AIDS)
- •Females pregnant or lactating.
- •History of Alcohol abuse.
- •History of Cancer within 3 years prior to screening.
- •Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors
- •Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
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 Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
时间窗: 4 weeks
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
时间窗: 4 weeks
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
次要结局
- Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median(4 weeks)
- Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean(4 weeks)