A Phase 3, Randomized, Double-Blind, Double Dummy, Multicenter, Parallel Group Comparison Study to Evaluate Efficacy and Safety of a Triple Therapy With TAK-438, Amoxicillin and Clarithromycin by Comparison With a Triple Therapy With AG-1749 (Lansoprazole), Amoxicillin and Clarithromycin for the First Line Eradication of H.Pylori
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 650
- 主要终点
- H. pylori eradication rate 4 weeks after completion of first-line therapy
研究概览
简要总结
The purpose of this study is to confirm the efficacy of triple therapy with TAK-438, Amoxicillin and Clarithromycin, twice daily (BID) by demonstrating its non-inferiority to triple therapy with Lansoprazole, Amoxicillin and Clarithromycin in H. pylori-positive patients with scarred gastric or duodenal ulcers.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be H. pylori-positive patients at baseline (Visit 1)
- •Participants must be endoscopically confirmed to have scarred gastric ulcer or duodenal ulcer at baseline (Visit 1).
- •However, if a history of ulcers is confirmed by the medical interview or previous medical record, Participants whose gastric ulcer scar or duodenal ulcer scar has disappeared may be included in the study.
- •Outpatient (including inpatient for examination)
排除标准
- •Participants who have received H.pylori eradication treatment
- •Participants who have either acute upper gastrointestinal bleeding, gastric ulcer [mucosal defect (with white coating including clot adherence) of 3 mm or larger in size], duodenal ulcer [mucosal defect (with white coating including clot adherence) of 3 mm or larger in size], acute gastric mucosal lesion (AGML), or acute duodenal mucosal lesion (ADML) on endoscopic examination at baseline (Visit 1).
- •However, participants with gastric erosion or duodenal erosion may be included in the study.
- •Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (ex, resection of upper gastrointestinal tract, vagotomy, etc)
- •Participants who cannot be treated with medicinal treatment (ex, perforation, pyloric stenosis or large hemorrhage, etc)
- •Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
- •Participants with hepatic or renal impairment receiving treatment with colchicines
- •Participants who have a history of hypersensitivity or allergy to TAK-438 (including its excipients), PPIs, penicillin antibiotics, macrolide antibiotics, or antitrichomonal agents
- •Participants with infectious mononucleosis
- •Participants with an organic disease of the brain or spinal cord
研究组 & 干预措施
TAK-438 20 mg BID
TAK-438 20 mg, tablets, orally, twice daily for 1 week
Lansoprazole placebo-matching capsules, orally, twice daily for 1 week
Amoxicillin 750 mg, capsules, orally, twice daily for 1 week
Clarithromycin 200 or 400 mg, tablets, orally, twice daily for 1 week
干预措施: TAK-438 (Drug)
TAK-438 20 mg BID
TAK-438 20 mg, tablets, orally, twice daily for 1 week
Lansoprazole placebo-matching capsules, orally, twice daily for 1 week
Amoxicillin 750 mg, capsules, orally, twice daily for 1 week
Clarithromycin 200 or 400 mg, tablets, orally, twice daily for 1 week
干预措施: Amoxicillin (Drug)
TAK-438 20 mg BID
TAK-438 20 mg, tablets, orally, twice daily for 1 week
Lansoprazole placebo-matching capsules, orally, twice daily for 1 week
Amoxicillin 750 mg, capsules, orally, twice daily for 1 week
Clarithromycin 200 or 400 mg, tablets, orally, twice daily for 1 week
干预措施: Clarithromycin (Drug)
Lansoprazole 30 mg BID
TAK-438 placebo-matching tablets, orally, twice daily for 1 week
Lansoprazole 30 mg, capsules, orally, twice daily for 1 week
Amoxicillin 750 mg, capsules, orally, twice daily for 1 week
Clarithromycin 200 or 400 mg, tablets, orally, twice daily for 1 week
干预措施: Lansoprazole (Drug)
Lansoprazole 30 mg BID
TAK-438 placebo-matching tablets, orally, twice daily for 1 week
Lansoprazole 30 mg, capsules, orally, twice daily for 1 week
Amoxicillin 750 mg, capsules, orally, twice daily for 1 week
Clarithromycin 200 or 400 mg, tablets, orally, twice daily for 1 week
干预措施: Amoxicillin (Drug)
Lansoprazole 30 mg BID
TAK-438 placebo-matching tablets, orally, twice daily for 1 week
Lansoprazole 30 mg, capsules, orally, twice daily for 1 week
Amoxicillin 750 mg, capsules, orally, twice daily for 1 week
Clarithromycin 200 or 400 mg, tablets, orally, twice daily for 1 week
干预措施: Clarithromycin (Drug)
结局指标
主要结局
H. pylori eradication rate 4 weeks after completion of first-line therapy
时间窗: 4-weeks post-dose (first-line therapy)
The participants are judged to be H. pylori-negative or H. pylori-positive based on the 13C-Urea Breath Test.
次要结局
- H. pylori eradication rate 4 weeks after completion of second-line therapy(4-weeks post-dose (second-line therapy))