An observational study in Reflux Esophagitis, sponsored by Takeda. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by Takeda · Observational
Among 10 studies in Esophagitis, Peptic by Takeda — none open to participants now, none under way, none of them phase 3. Esophagitis, Peptic · Takeda.
Among the 10 studies in Esophagitis, Peptic by Takeda, this one is one of 2 that started in 2016, is one of 3 observational ones, and was the 8th registered.
83 studies on the registry are indexed under Esophagitis, Peptic; 16 are open to participants now.
This study's enrollment of 1,237 is above the median of 535 across 22 observational studies indexed under Esophagitis, Peptic.
Browse Esophagitis, Peptic studies →None of the 10 studies in Esophagitis, Peptic by Takeda is open now.
Of the 7 Esophagitis, Peptic studies recruiting now, 3 (43%) set no upper age limit and 3 (43%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2016.
Median enrollment 451 across the 7 interventional studies, 3,000 across the 3 observational. Of the 10 that completed or were terminated, 9 (90%) have results posted.
Takeda is the lead sponsor of 1,026 studies on the registry; 89 are open to participants now.
Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Esophagitis, Peptic by Takeda, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
This multi-center observational trial will be conducted in Japan.
The study population will consist of participants with a diagnosis of reflux esophagitis and received dose of vonoprazan in the routine medical care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Vonoprazan
Vonoprazan tablets
Also known as: Takecab tablets, TAK-438
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.
Time frame: Up to 12 months
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Month 6 and at Month 12
Participants took part in the survey at 122 investigative sites in Japan, from 01 March 2016 to 31 August 2018.
| Milestone | Vonoprazan 10 mg or 20 mg |
|---|---|
| Started | 1237 |
| Completed | 1174 |
| Not completed | 63 |
| Withdrew: Case report forms uncollected | 9 |
| Withdrew: Protocol deviation | 54 |
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.
| Percentage of Participants | Vonoprazan 10 mg or 20 mg |
|---|---|
| Percentage of Participants Who Had One or More Adverse Drug Reactions | 2.30 |
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.
| Percentage of Participants | Vonoprazan 10 mg or 20 mg |
|---|---|
| Endoscopic Relapse Rate | 4.00 (2.35 to 6.33) |
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.
| Participants | Vonoprazan 10 mg or 20 mg |
|---|---|
| Baseline — Mild | 368 |
| Baseline — Moderate | 270 |
| Baseline — Severe | 26 |
| Month 6 — Mild | 136 |
| Month 6 — Moderate | 17 |
| Month 6 — Severe | 2 |
| Month 12 — Mild | 84 |
| Month 12 — Moderate | 7 |
| Month 12 — Severe | 0 |
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.
| Participants | Vonoprazan 10 mg or 20 mg |
|---|---|
| Baseline — Mild | 292 |
| Baseline — Moderate | 159 |
| Baseline — Severe | 20 |
| Month 6 — Mild | 94 |
| Month 6 — Moderate | 16 |
| Month 6 — Severe | 2 |
| Month 12 — Mild | 52 |
| Month 12 — Moderate | 11 |
| Month 12 — Severe | 0 |
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.
| Participants | Vonoprazan 10 mg or 20 mg |
|---|---|
| Baseline — Mild | 196 |
| Baseline — Moderate | 77 |
| Baseline — Severe | 10 |
| Month 6 — Mild | 61 |
| Month 6 — Moderate | 7 |
| Month 6 — Severe | 2 |
| Month 12 — Mild | 40 |
| Month 12 — Moderate | 5 |
| Month 12 — Severe | 0 |
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.
| Participants | Vonoprazan 10 mg or 20 mg |
|---|---|
| Baseline — Mild | 80 |
| Baseline — Moderate | 23 |
| Baseline — Severe | 5 |
| Month 6 — Mild | 29 |
| Month 6 — Moderate | 7 |
| Month 6 — Severe | 2 |
| Month 12 — Mild | 21 |
| Month 12 — Moderate | 4 |
| Month 12 — Severe | 0 |
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.
| Participants | Vonoprazan 10 mg or 20 mg |
|---|---|
| Baseline — Mild | 167 |
| Baseline — Moderate | 52 |
| Baseline — Severe | 13 |
| Month 6 — Mild | 63 |
| Month 6 — Moderate | 6 |
| Month 6 — Severe | 0 |
| Month 12 — Mild | 40 |
| Month 12 — Moderate | 4 |
| Month 12 — Severe | 0 |
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.
| Participants | Vonoprazan 10 mg or 20 mg |
|---|---|
| Baseline — Mild | 97 |
| Baseline — Moderate | 49 |
| Baseline — Severe | 12 |
| Month 6 — Mild | 28 |
| Month 6 — Moderate | 3 |
| Month 6 — Severe | 1 |
| Month 12 — Mild | 9 |
| Month 12 — Moderate | 1 |
| Month 12 — Severe | 0 |
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.
| Participants | Vonoprazan 10 mg or 20 mg |
|---|---|
| Baseline — Mild | 91 |
| Baseline — Moderate | 31 |
| Baseline — Severe | 5 |
| Month 6 — Mild | 40 |
| Month 6 — Moderate | 5 |
| Month 6 — Severe | 3 |
| Month 12 — Mild | 28 |
| Month 12 — Moderate | 5 |
| Month 12 — Severe | 0 |
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.
| Participants | Vonoprazan 10 mg or 20 mg |
|---|---|
| Baseline — Mild | 69 |
| Baseline — Moderate | 25 |
| Baseline — Severe | 2 |
| Month 6 — Mild | 28 |
| Month 6 — Moderate | 9 |
| Month 6 — Severe | 1 |
| Month 12 — Mild | 20 |
| Month 12 — Moderate | 1 |
| Month 12 — Severe | 0 |
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.
| Participants | Vonoprazan 10 mg or 20 mg |
|---|---|
| Baseline — Mild | 138 |
| Baseline — Moderate | 60 |
| Baseline — Severe | 8 |
| Month 6 — Mild | 62 |
| Month 6 — Moderate | 7 |
| Month 6 — Severe | 2 |
| Month 12 — Mild | 51 |
| Month 12 — Moderate | 6 |
| Month 12 — Severe | 0 |
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.
| Participants | Vonoprazan 10 mg or 20 mg |
|---|---|
| Baseline — Mild | 67 |
| Baseline — Moderate | 33 |
| Baseline — Severe | 5 |
| Month 6 — Mild | 35 |
| Month 6 — Moderate | 9 |
| Month 6 — Severe | 2 |
| Month 12 — Mild | 15 |
| Month 12 — Moderate | 4 |
| Month 12 — Severe | 0 |
Collected over Up to 12 months. Non-serious events are listed at a 0.5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vonoprazan 10 mg or 20 mg | 7/1,174 (0.6%) | 15/1,174 (1.3%) | 11/1,174 (0.9%) |
| Event | Vonoprazan 10 mg or 20 mg |
|---|---|
| PneumoniaInfections and infestations | 2/1174 |
| Platelet count decreasedInvestigations | 2/1174 |
| Peritonitis bacterialInfections and infestations | 1/1174 |
| Acute LeukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/1174 |
| LymphomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/1174 |
| Myelodysplastic syndromeNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/1174 |
| Hepatic cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/1174 |
| MyelopathyNervous system disorders | 1/1174 |
| Subarachnoid haemorrhageNervous system disorders | 1/1174 |
| Angina unstableCardiac disorders | 1/1174 |
| Event | Vonoprazan 10 mg or 20 mg |
|---|---|
| DiarrhoeaGastrointestinal disorders | 11/1174 |
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Age, Continuous(Years) | Vonoprazan 10 mg or 20 mg |
|---|---|
| Mean | 67.8 ± 13.60 |
| Sex: Female, Male(Participants) | Vonoprazan 10 mg or 20 mg |
|---|---|
| Female | 683 |
| Male | 491 |
| Race and Ethnicity Not Collected(Participants) | Vonoprazan 10 mg or 20 mg |
|---|
| Region of Enrollment(Participants) | Vonoprazan 10 mg or 20 mg |
|---|---|
| Japan | 1174 |
| Duration of Diagnosis of Reflux esophagitis(Days) | Vonoprazan 10 mg or 20 mg |
|---|---|
| Mean | 1109.5 ± 1449.98 |
| Healthcare Category(Participants) | Vonoprazan 10 mg or 20 mg |
|---|---|
| Outpatient | 1146 |
| Inpatient | 28 |
| Predisposition to Hypersensitivity(Participants) | Vonoprazan 10 mg or 20 mg |
|---|---|
| Had No Predisposition to Hypersensitivity | 1045 |
| Had Predisposition to Hypersensitivity | 72 |
| Unknown | 57 |
| Medical Complications(Participants) | Vonoprazan 10 mg or 20 mg |
|---|---|
| Had No Medical Complications | 394 |
| Had Medical Complications | 780 |
10 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
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