A Phase 3, Open-Label Study to Assess the Long-Term Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 591
- 主要终点
- Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values
研究概览
简要总结
The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.
详细描述
This open-label study is intended to determine the long-term safety profile of dexlansoprazole MR over 12 months of dosing with 60 mg once-daily (QD) or 90 mg QD in subjects with gastroesophageal reflux disease (GERD), including those with esophageal erosions.
Prior to a protocol amendment, 300 subjects successfully completed one of the symptomatic nonerosive gastroesophageal reflux studies T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) in which they were randomly assigned to receive placebo or dexlansoprazole MR 60 or 90 mg QD. Subjects who were enrolled from one of these symptomatic GERD studies were randomly assigned in a 1:1 ratio to receive either dexlansoprazole MR 60 or 90 mg QD in this long-term study.
After implementation of protocol amendment #4, an additional 300 subjects with gastroesophageal reflux disease including those with erosive esophagitis will be enrolled and treated with dexlansoprazole MR 90 mg QD for 12 months.
Approximately 200 study sites in the U.S. will participate.
For all analyses involving visits during treatment from subjects enrolled prior to protocol amendment #4, baseline refers to pretreatment to Study T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758). For subjects enrolled under protocol amendment #4, baseline is based on screening or predosing measurement.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have successfully completed either T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease with or without erosive esophagitis.
排除标准
- •Any condition that may require inpatient surgery during the course of the study.
- •Use of prescription or non-prescription proton pump inhibitors, histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study.
- •Use of antacids [except for study supplied Gelusil®].
- •Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study.
- •Evidence of uncontrolled systemic disease.
- •Allergy to any proton pump inhibitor including Prilosec, Nexium, Prevacid, or others, any component of dexlansoprazole MR, or Gelusil/antacid.
- •Need to take blood thinners.
- •Need to take more than 12 doses of non-steroidal anti-inflammatory drugs per month.
- •Had cancer (except basal cell cancer of the skin) within 3 years prior to screening.
- •Has other esophageal disease including Barrett's esophagus or strictures requiring dilation.
- •Has had radiation or cryotherapy to the esophagus.
- •Has active gastric or duodenal ulcers within 4 weeks of starting study drug.
- •Has a history of hypersecretory conditions such as Zollinger Ellison Syndrome.
- •History of alcohol abuse.
- •Has acquired immunodeficiency syndrome.
- •Has had acute upper gastrointestinal bleeding within 4 weeks of endoscopy.
- •Received a blood product transfusion within 3 months of taking the first dose of study drug.
- •Has previously participated in another dexlansoprazole MR long-term treatment clinical trial.
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)
结局指标
主要结局
Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values
时间窗: Baseline and Month 12
Mean Change From Baseline to Month 12 for Red Blood Cell Count Values
时间窗: Baseline and Month 12
Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values
时间窗: Baseline and Month 12
Mean Change From Baseline to Month 12 for Platelet Count Values
时间窗: Baseline and Month 12
Mean Change From Baseline to Month 12 for White Blood Cell Count Values
时间窗: Baseline and Month 12
Mean Change From Baseline to Month 12 for Hemoglobin Values
时间窗: Baseline and Month 12
Mean Change From Baseline to Month 12 for Hematocrit Values
时间窗: Baseline and Month 12
Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference.
Mean Change From Baseline to Month 12 for Creatinine Values
时间窗: Baseline and Month 12
Mean Change From Baseline to Month 12 for Calcium Values
时间窗: Baseline and Month 12
Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values
时间窗: Baseline and Month 12
Mean Change From Baseline to Month 12 for Total Bilirubin Values
时间窗: Baseline and Month 12
Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values
时间窗: Baseline and Month 12
Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values
时间窗: Baseline and Month 12
Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values
时间窗: Baseline and Month 12
Mean Change From Baseline to Month 12 for Serum Gastrin Levels
时间窗: Baseline and Month 12
Mean Change From Baseline to Month 12 for Systolic Blood Pressure
时间窗: Baseline and Month 12
Mean Change From Baseline to Month 12 for Diastolic Blood Pressure
时间窗: Baseline and Month 12
Mean Change From Baseline to Month 12 for Pulse Rate
时间窗: Baseline and Month 12
Changes From Baseline to Final Visit in Antrum Biopsy Results
时间窗: Baseline and Final Visit (up to 12 months)
Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.
Changes From Baseline to Final Visit in Fundus Biopsy Results
时间窗: Baseline and Final Visit (up to 12 months)
Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.
次要结局
- Mean Change From Baseline to Month 1 for PAGI-QOL Total Score(Baseline and Month 1)
- Mean Change From Baseline to Month 3 for PAGI-QOL Total Score(Baseline and Month 3)
- Mean Change From Baseline to Month 6 for PAGI-QOL Total Score(Baseline and Month 6)
- Mean Change From Baseline to Month 9 for PAGI-QOL Total Score(Baseline and Month 9)
- Mean Change From Baseline to Month 12 for PAGI-QOL Total Score(Baseline and Month 12)
- Mean Change From Baseline to Month 1 for PAGI-SYM Total Score(Baseline and Month 1)
- Mean Change From Baseline to Month 3 for PAGI-SYM Total Score(Baseline and Month 3)
- Mean Change From Baseline to Month 6 for PAGI-SYM Total Score(Baseline and Month 6)
- Mean Change From Baseline to Month 9 for PAGI-SYM Total Score(Baseline and Month 9)
- Mean Change From Baseline to Month 12 for PAGI-SYM Total Score(Baseline and Month 12)