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

Overview

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 Title of Study: “Special Drug Use Surveillance of Takecab Tablets for “Maintenance Therapy of Reflux Esophagitis: Long-term Use””

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 31, 2018

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.

Interventions

  • Drug: Vonoprazan
    • Vonoprazan tablets

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants Who Had One or More Adverse Drug Reactions
    • Time Frame: 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.

Secondary Measures

  • Endoscopic Relapse Rate
    • Time Frame: From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), up to 12 months
    • Endoscopic relapse rate was defined as a percentage of participants who met the criteria of Grade A to D in the modified Los Angeles (LA) classification. The modified LA classification graded endoscopic findings as follows- Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity; Grade A: non-confluent mucosal breaks <5 mm in length; Grade B: nonconfluent mucosal breaks ≥ 5 mm in length; Grade C: confluent mucosal breaks <75% circumferential; Grade D: confluent mucosal breaks >=75% circumferential.
  • Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn
    • Time Frame: Baseline, Month 6 and at Month 12
    • Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe heartburn at each time points were reported.
  • Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux
    • Time Frame: Baseline, Month 6 and at Month 12
    • Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe acid reflux at each time points were reported.
  • Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness
    • Time Frame: Baseline, Month 6 and at Month 12
    • Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe postprandial fullness at each time points were reported.
  • Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation
    • Time Frame: Baseline, Month 6 and at Month 12
    • Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe early satiation at each time points were reported.
  • Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain
    • Time Frame: Baseline, Month 6 and at Month 12
    • Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe epigastric pain at each time points were reported.
  • Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning
    • Time Frame: Baseline, Month 6 and at Month 12
    • Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe epigastric burning at each time points were reported.
  • Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating
    • Time Frame: Baseline, Month 6 and at Month 12
    • Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe abdominal bloating at each time points were reported.
  • Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting
    • Time Frame: Baseline, Month 6 and at Month 12
    • Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe nausea/vomiting at each time points were reported.
  • Number of Participants With Recorded Severity of Subjective Symptoms of Belching
    • Time Frame: Baseline, Month 6 and at Month 12
    • Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe belching at each time points were reported.
  • Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia
    • Time Frame: Baseline, Month 6 and at Month 12
    • Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe anorexia at each time points were reported.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Takeda
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, Takeda

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