A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole (60 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis, and Maintenance of Healing in Subjects With Healed Erosive Esophagitis With Dexlansoprazole (30 mg QD) and Placebo
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 37
- 试验地点
- 25
- 主要终点
- Healing Period: Percentage of Participants With Complete Healing of EE at Week 8
研究概览
简要总结
The purpose of this study is to determine the efficacy of dexlansoprazole compared to lansoprazole in healing erosive esophagitis (EE) in Chinese participants.
详细描述
The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat people who have EE. This study will look at erosive esophageal healing in people who take dexlansoprazole.
The study will enroll approximately 450 participants. Participants will be randomly assigned to one of the two treatment groups with 1:1 ratio-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- Dexlansoprazole 60 mg
- Lansoprazole 30 mg
After 8 weeks of treatment, participants will be evaluated to assess esophageal healing. If the EE is healed participants will be randomly assigned to one of two different treatment groups with 1:1 ratio:
- Dexlansoprazole 30 mg
- Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient.
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
- Quadruple (Participant, Care Provider, 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
- •Has endoscopically confirmed EE as defined by the LA Classification Grading System (A-D).
排除标准
- •Participant is required to take excluded medications, or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study evaluation period.
- •Has a hypersensitivity to any proton pump inhibitor (PPI) (including, but not limited to, lansoprazole, omeprazole, rabeprazole, pantoprazole, esomeprazole or ilaprazole), any component of dexlansoprazole, or antacid (example, magnesium trisilicate or similar antacid).
- •Had a history of cancer, (except basal cell carcinoma of the skin), that has not been in remission for at least 5 years prior to Screening.
- •Has a known history or any suspicious Barrett's esophagus with dysplastic changes seen during screening endoscopy.
- •Developed acute upper gastrointestinal bleeding, gastric ulcer (a mucosal defect with white coating) or duodenal ulcer (a mucosal defect with white coating), within 30 days before the start of the Screening Visit (with the possible inclusion of those with gastric or duodenal erosion). The participant requires chronic use (>12 doses per month) of non steroidal anti-inflammatory drugs (NSAIDs) including cyclooxygenase-2 (COX-2) NSAIDs within 30 days prior to the Screening Period and throughout the study.
- •Has comorbidities that could affect the esophagus (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal strictures); a history of radiotherapy or cryotherapy of the esophagus; and a history of corrosive or physiochemical injury (with the possible inclusion in the study of those with Schatzki's ring).
- •Has a history of surgical procedures that may affect the esophagus (example, fundoplication and mechanical dilatation for esophageal strictures) or a history of gastric or duodenal surgery other than endoscopic removal of benign polyps.
- •Participant is known to have the acquired immunodeficiency syndrome (AIDS) or hepatitis, including hepatitis virus carriers (that is, hepatitis B surface antigen HBs-antigen (HBsAg) positive or hepatitis C virus (HCV)-antibody positive).
- •Has current Zollinger-Ellison syndrome (gastric acid hyper secretion) or a history of gastric acid hypersecretion.
- •Participant is scheduled for surgery that requires hospitalization or requires surgical treatment during his/her participation in the study.
- •Has donated or lost >300 milliliter (mL) blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug.
- •Has a history of alcohol or drug abuse (defined as any illicit drug use), or drug addiction in the 12 months prior to Screening.
- •The participant with positive serology result of Helicobacter pylori (H. pylori) that needs eradication therapy during the study participation period as anticipated by the investigator.
研究组 & 干预措施
Healing Period: Dexlansoprazole 60 mg
Dexlansoprazole 60 milligram (mg), delayed-release capsules, orally, once daily for up to 8 weeks in the Healing Period.
干预措施: Dexlansoprazole (Drug)
Healing Period: Lansoprazole 30 mg
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks in the Healing Period.
干预措施: Lansoprazole (Drug)
Maintenance Period: Dexlansprazole 30 mg
Participants who will be healed at Week 8 will be randomized to receive dexlansoprazole 30 mg, delayed-release capsules, orally, once daily for up to 6 months in the Maintenance period.
干预措施: Dexlansoprazole (Drug)
Maintenance Period: Placebo
Participants who will be healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 6 months in the Maintenance period.
干预措施: Placebo (Drug)
结局指标
主要结局
Healing Period: Percentage of Participants With Complete Healing of EE at Week 8
时间窗: Week 8
Percentage of participants with complete healing of EE was assessed by endoscopy. EE was graded according to the Los Angeles (LA) classification of esophagitis grading system, based on the extent of visible mucosal breaks seen in the esophagus according to the following: Grade O (no mucosal breaks); Grade A (\>=1 mucosal break no longer than 5 millimeter \[mm\] that does not extend between the tops of 2 mucosal folds); Grade B (\>=1 mucosal break greater than \[\>\] 5 mm that does not extend between the tops of 2 mucosal folds); Grade C (\>=1 mucosal break that is continuous between the tops of 2 or more mucosal folds, but involves \<75 percent (%) of the circumference); Grade D (\>=1 mucosal break which involves \>=75% of the circumference). Healing is defined as LA Grade O.
次要结局
- Maintenance Period: Percentage of Participants Who Maintained Complete Healing of EE at Month 6(Month 6)