Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"

Takeda

Status: Completed

Conditions: Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis

Treatments: Drug: Vonoprazan

Study type: Observational

Funder types: Industry

Identifiers

NCT03214952

Vonoprazan-5001

JapicCTI-163177 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,183 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

3,183 participants in 1 patient group

Vonoprazan 20 mg

Description:

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.

Treatment:

Drug: Vonoprazan