Special Drug Use Surveillance of Takecab Tablets for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,237
- 试验地点
- 1
- 主要终点
- Percentage of Participants 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 long-term administration of vonoprazan tablets when used as maintenance therapy for reflux esophagitis in routine clinical settings.
详细描述
The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat patients who have reflux esophagitis.
This survey will look at the safety and effectiveness of long-term administration of vonoprazan tablets when used as maintenance therapy for reflux esophagitis in routine clinical settings. The survey will enroll approximately 1000 participants.
- Vonoprazan 10 mg or 20 mg
This multi-center observational trial 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 who require maintenance therapy for relapsed/recurrent reflux esophagitis
排除标准
- •Participants meeting the criteria of grade A to D according to the Los Angeles classification (Hoshihara's modification), by means of endoscopy at the initiation of maintenance therapy with vonoprazan tablets
- •Participants with a previous history of hypersensitivity to ingredients in vonoprazan tablets
- •Participants taking atazanavir sulfate or rilpivirine hydrochloride
研究组 & 干预措施
Vonoprazan 10 mg or 20 mg
Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. 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 Who Had One or More Adverse Drug Reactions
时间窗: Up to 12 months
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 administered drug.
次要结局
- Endoscopic Relapse Rate(From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), up to 12 months)
- Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness(Baseline, Month 6 and at Month 12)
- Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn(Baseline, Month 6 and at Month 12)
- Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation(Baseline, Month 6 and at Month 12)
- Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain(Baseline, Month 6 and at Month 12)
- Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating(Baseline, Month 6 and at Month 12)
- Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia(Baseline, Month 6 and at Month 12)
- Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux(Baseline, Month 6 and at Month 12)
- Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning(Baseline, Month 6 and at Month 12)
- Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting(Baseline, Month 6 and at Month 12)
- Number of Participants With Recorded Severity of Subjective Symptoms of Belching(Baseline, Month 6 and at Month 12)