Clinical trial NCT03214952: Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"
Official title: Drug Use Surveillance of Takecab Tablets for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-07-12
Enrollment: 3183
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of participants with a diagnosis of gastric ulcer, duodenal ulcer, and reflux esophagitis and receive Vonoprazan in the routine clinical setting.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

- Participants with gastric ulcer, duodenal ulcer, and reflux esophagitis

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants With Gastric Ulcer Who Had One or More Adverse Drug Reactions
timeFrame: Up to 8 weeks
measure: Percentage of Participants With Duodenal Ulcer Who Had One or More Adverse Drug Reactions
timeFrame: Up to 6 weeks
measure: Percentage of Participants With Reflux Esophagitis Who Had One or More Adverse Drug Reactions
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Endoscopic Cure Rate in Participants With Gastric Ulcer
timeFrame: Up to 8 weeks
measure: Endoscopic Cure Rate in Participants With Duodenal Ulcer
timeFrame: Up to 6 weeks
measure: Endoscopic Cure Rate in Participants With Reflux Esophagitis
timeFrame: Up to 8 weeks
measure: Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved
timeFrame: Baseline and at the end of the survey (up to 8 weeks)
measure: Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved
timeFrame: Baseline and at the end of the survey (up to 6 weeks)
measure: Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved
timeFrame: Baseline and at the end of the survey (up to 8 weeks)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: