Clinical trial NCT03214081: Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
Official title: Special Drug Use Surveillance of Takecab Tablets for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reflux Esophagitis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-07-11
Enrollment: 1237
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of participants with a diagnosis of reflux esophagitis and received dose of vonoprazan in the routine medical care.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Had One or More Adverse Drug Reactions
timeFrame: Up to 12 months
Secondary outcomes:
measure: Endoscopic Relapse Rate
timeFrame: From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), up to 12 months
measure: Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn
timeFrame: Baseline, Month 6 and at Month 12
measure: Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux
timeFrame: Baseline, Month 6 and at Month 12
measure: Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness
timeFrame: Baseline, Month 6 and at Month 12
measure: Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation
timeFrame: Baseline, Month 6 and at Month 12
measure: Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain
timeFrame: Baseline, Month 6 and at Month 12
measure: Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning
timeFrame: Baseline, Month 6 and at Month 12
measure: Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating
timeFrame: Baseline, Month 6 and at Month 12
measure: Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting
timeFrame: Baseline, Month 6 and at Month 12
measure: Number of Participants With Recorded Severity of Subjective Symptoms of Belching
timeFrame: Baseline, Month 6 and at Month 12
measure: Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia
timeFrame: Baseline, Month 6 and at Month 12
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: