Drug Use Surveillance of Takecab Tablets for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,183
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Gastric Ulcer Who Had One or More Adverse Drug Reactions
研究概览
简要总结
The purpose of this survey is to evaluate the safety and effectiveness of vonoprazan tablets in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting.
详细描述
The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat patients who have gastric ulcer, duodenal ulcer, and reflux esophagitis.
This survey will look at the safety and effectiveness of vonoprazan in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting. The survey will enroll approximately 3000 participants.
- Vonoprazan 20 mg
This multi-center survey will be conducted in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with gastric ulcer, duodenal ulcer, and reflux esophagitis
排除标准
- •Participants with previous history of hypersensitivity to ingredients in Takecab tablets
- •Participants taking atazanavir sulfate or rilpivirine hydrochloride
- •Participants meeting the criteria of scarring stage (S1, S2) of endoscopic classification defined by Sakita and Miwa at the start of the treatment with Takecab tablets, in the case that the target disease is gastric ulcer or duodenal ulcer
- •Participants meeting the criteria of Grade N or Grade M of Los Angeles classification (Hoshihara's modification) at the start of the treatment with Takecab tablets, in the case that the target disease is reflux esophagitis.
研究组 & 干预措施
Vonoprazan 20 mg
The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.
干预措施: Vonoprazan (Drug)
结局指标
主要结局
Percentage of Participants With Gastric Ulcer Who Had One or More Adverse Drug Reactions
时间窗: Up to 8 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to the administered drug.
Percentage of Participants With Duodenal Ulcer Who Had One or More Adverse Drug Reactions
时间窗: Up to 6 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to the administered drug.
Percentage of Participants With Reflux Esophagitis Who Had One or More Adverse Drug Reactions
时间窗: Up to 8 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to the administered drug.
次要结局
- Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved(Baseline and at the end of the survey (up to 6 weeks))
- Endoscopic Cure Rate in Participants With Gastric Ulcer(Up to 8 weeks)
- Endoscopic Cure Rate in Participants With Duodenal Ulcer(Up to 6 weeks)
- Endoscopic Cure Rate in Participants With Reflux Esophagitis(Up to 8 weeks)
- Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved(Baseline and at the end of the survey (up to 8 weeks))
- Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved(Baseline and at the end of the survey (up to 8 weeks))