NCT01568398已完成3 期
A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Low-Dose Aspirin Therapy
Takeda0 个研究点目标入组 27 人开始时间: 2012年5月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 主要终点
- Adverse Event
研究概览
简要总结
The purpose of this study is to study the safety and efficacy of TAK-438, once daily (QD), in participants with a history of gastric or duodenal ulcer requiring long-term low-dose aspirin therapy will be investigated.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 who, in the opinion of the principal investigator or subinvestigator, are capable of understanding the details of the study and complying with them.
- •Prior to study commencement, participants who are capable of signing and dating the information/consent form.
- •Participants with a chronic disease (ischaemic cardiac disease, ischaemic cerebrovascular disease, etc.) which requires continuous low-dose aspirin oral therapy for prevention of thromboembolism during the treatment period.
- •Participants who meet either 1 or 2 below according to gastric or duodenal endoscopy:
- •Ulcer scar (defined, in this study, as regenerative mucosa, convergence of mucosal fold, gastric wall transformation, etc) has been confirmed during endoscopy on the study drug initiation day (Visit 2).
- •Ulcer (mucosal defects of 3 mm or larger with white moss) or ulcer scar has been endoscopically confirmed before the study drug initiation day (Visit 2).
- •Outpatient participants (inpatients for examinations are acceptable).
- •Women with child-bearing potential must agree to routinely take appropriate contraceptive measures throughout treatment period, from giving consent to the study until 4 weeks after the final dose.
排除标准
- •Participants who received treatment with another study drug (including approved drugs under post-marketing surveillance) within 84 days prior to commencement of screening
- •Participants who have previously received TAK-438 in a clinical study or as a treatment
- •Participants who are employees of institutions participating in this study and family members of such employees, participants in a dependent relationship with employees of institutions involved in conduct of the study (e.g., spouse, parent, child, sibling), and participants who are under duress in giving their consent
- •Participant who have donated 400 mL or more of blood within 90 days prior to the commencement of screening
- •Participants with a plan to change the type, dosage or administration of low-dose aspirin.
- •Participants with ulcer (mucosal defects of 3 mm or larger with white moss) or active hemorrhage confirmed during gastric or duodenal endoscopy on the study drug initiation day (Visit 2)
- •Participants with small intestinal hemorrhage, large intestinal hemorrhage, or gastrointestinal hemorrhage of unknown cause
- •Participants with a history of surgery or scheduled surgery influencing gastric acid secretion (resection of upper gastrointestinal tract or vagotomy etc)
- •Participants with a history or complication of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
- •Participants with a history or complication of aspirin asthma
- •Participants who have a history of hypersensitivity or allergy to TAK-438 (including its excipients) or aspirin or salicylic acid agents.
- •Participants with current use of illicit drug or a history of drug abuse. and/or alcohol dependence within one year prior to the commencement of screening
- •Participants who require treatment with prohibited concomitant drugs or therapies (see 7.3)
- •Female participants who are pregnant or lactating; those who plan to become pregnant or donate ova during treatment period, from giving consent until 4 weeks after final dose
- •Participants with serious central nervous system disorders, cardiovascular disease, pulmonary disease, hepatic disease, renal disease, metabolic disease, gastrointestinal disorders, urinary disorders, endocrine disease, or blood dyscrasia
- •Participants who plan to undergo surgery requiring hospitalization or requires surgery during the study period
- •Participants with a history of a malignancy (or treatment thereof) within 5 years prior to the commencement of screening; however, participants with completely cured of basal cell carcinoma of skin or carcinoma in situ of the cervix may be included in the study.
- •Participants with acquired immune deficiency syndrome (AIDS; including HIV carriers) or hepatitis (including viral hepatitis carriers [HBs antigen positive or HCV antibody positive]); however, Participants who are hepatitis C virus (HCV) antigen negative or HCV-RNA negative may be included in the study.
- •Participants who meet either of the following laboratory test values at the beginning of screening (Visit 1)
- •Serum creatinine value: higher than 2 mg/dL
- •Alanine transaminase (ALT) or aspartate aminotransferase (AST): higher than 2.5 × the upper limit of normal
- •Total bilirubin: higher than 2.0 × the upper limit of normal
研究组 & 干预措施
TAK-438 20 mg QD
Experimental
干预措施: TAK-438 (Drug)
结局指标
主要结局
Adverse Event
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
相似试验
已完成
3 期
A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Non-Steroid Anti-Inflammatory Drug (NSAID) TherapyGastric UlcerDuodenal UlcerNCT01568385Takeda30
已完成
3 期
Phase 3 Study of TAK-438 10 mg in the Treatment of Non-Erosive Gastroesophageal Reflux Disease (NERD)Non-erosive Gastroesophageal Reflux DiseaseNCT02954848Takeda484
已完成
3 期
Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric UlcerGastric UlcerNCT01452711Takeda482
已完成
3 期
Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive EsophagitisErosive EsophagitisNCT01452776Takeda305
已完成
3 期
Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux DiseaseNon-erosive Gastroesophageal Reflux DiseaseNCT01474369Takeda827