Reflux EsophagitisNCT03214081
Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
An observational study of Reflux Esophagitis, run by Takeda at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Reflux Esophagitis
- What is being tested?
- Vonoprazan
- Type of treatment
- Pill or oral medicine
- How many people
- 1,237 participants
- Where
- 1 siteJapan
- Study dates
- 1 Mar 2016to 31 Aug 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Participants who require maintenance therapy for relapsed/recurrent reflux esophagitis
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Special Drug Use Surveillance of Takecab Tablets for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
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.
Read the 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.
- Conditions
- Reflux Esophagitis
- Being tested
- Vonoprazan
- Medical subject headings
- Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Also called Takecab tablets, TAK-438
Vonoprazan tablets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vonoprazan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Had One or More Adverse Drug Reactions
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.
Measured: Up to 12 months
Secondary outcomes (11)
Endoscopic Relapse Rate
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.
Measured: From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), up to 12 months
Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn
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.
Measured: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux
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.
Measured: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness
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.
Measured: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation
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.
Measured: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain
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.
Measured: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning
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.
Measured: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating
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.
Measured: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting
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.
Measured: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Belching
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.
Measured: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia
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.
Measured: Baseline, Month 6 and at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Mar 2016
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reflux EsophagitisStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214081
- Sponsor's protocol ID
- Vonoprazan-5003
- Other IDs
- JapicCTI-163202
- Status last verified
- May 2025
- First submitted
- 9 Jul 2017
- Last updated
- 10 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Publications
Manabe N, Matsuo M, Suzuki C. Long-term safety and effectiveness of vonoprazan as maintenance therapy for reflux esophagitis in Japan: a 12-month post-marketing surveillance study. Expert Opin Drug Saf. 2026 Apr 15:1-10. doi: 10.1080/14740338.2026.2612982. Online ahead of print.
PubMed 41982134
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Surveillance of Takecab Tablets for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
- ClinicalTrials.gov ID
- NCT03214081
- Acronym / sponsor ID
- Vonoprazan-5003
- Conditions
- Reflux Esophagitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,237 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Posted 23 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan 10 mg or 20 mg | – | Drug: VonoprazanUsually, 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Participants who require maintenance therapy for relapsed/recurrent reflux esophagitis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VonoprazanAlso: Takecab tablets, TAK-438Vonoprazan tablets | Drug | Vonoprazan 10 mg or 20 mg |
Primary outcome
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.
11 secondary outcomes
Endoscopic Relapse Rate
Time frame: From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), up to 12 months
Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn
Time frame: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux
Time frame: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness
Time frame: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation
Time frame: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain
Time frame: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning
Time frame: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating
Time frame: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting
Time frame: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Belching
Time frame: Baseline, Month 6 and at Month 12
Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia
Time frame: Baseline, Month 6 and at Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41982134Manabe N, Matsuo M, Suzuki C. Long-term safety and effectiveness of vonoprazan as maintenance therapy for reflux esophagitis in Japan: a 12-month post-marketing surveillance study. Expert Opin Drug Saf. 2026 Apr 15:1-10. doi: 10.1080/14740338.2026.2612982. Online ahead of print.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Related trials for Reflux Esophagitis
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Not yet recruitingPhase 4
PPI Dosing Per CYP2C19 Genotype
Gastroesophageal Reflux Disease With Esophagitis
Active, not recruitingPhase 3
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System Disorder, Dyspepsia
RecruitingObservational study
Preoperative Predictors of Symptom Improvement After Laparoscopic Fundoplication
Gastroesophageal Reflux Disease, Hiatal Hernia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reflux Esophagitis, run by Takeda at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Had One or More Adverse Drug Reactions (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03214081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.