Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"

Takeda

Status: Completed

Conditions: Reflux Esophagitis

Treatments: Drug: Vonoprazan

Study type: Observational

Funder types: Industry

Identifiers

NCT03214081

JapicCTI-163202 (Registry Identifier)

Vonoprazan-5003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,237 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who require maintenance therapy for relapsed/recurrent reflux esophagitis

Exclusion criteria

• 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

Trial design

1,237 participants in 1 patient group

Vonoprazan 10 mg or 20 mg

Description:

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.

Treatment:

Drug: Vonoprazan