N/A
Completed N=1,237
Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
Reflux Esophagitis
Source: ClinicalTrials.gov NCT03214081 ↗
Enrolled (actual)
1,237
Serious AEs
1.3%
Results posted
Oct 2019
Primary outcomePrimary: Percentage of Participants Who Had One or More Adverse Drug Reactions — 2.30 Percentage of Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Had One or More Adverse Drug Reactions |
2.30 | — |
| SECONDARY Endoscopic Relapse Rate |
4.00 | — |
| SECONDARY Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn |
368; 270; 26; 136; 17; 2 | — |
| SECONDARY Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux |
292; 159; 20; 94; 16; 2 | — |
| SECONDARY Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness |
196; 77; 10; 61; 7; 2 | — |
| SECONDARY Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation |
80; 23; 5; 29; 7; 2 | — |
| SECONDARY Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain |
167; 52; 13; 63; 6; 0 | — |
| SECONDARY Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning |
97; 49; 12; 28; 3; 1 | — |
| SECONDARY Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating |
91; 31; 5; 40; 5; 3 | — |
| SECONDARY Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting |
69; 25; 2; 28; 9; 1 | — |
| SECONDARY Number of Participants With Recorded Severity of Subjective Symptoms of Belching |
138; 60; 8; 62; 7; 2 | — |
| SECONDARY Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia |
67; 33; 5; 35; 9; 2 | — |
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
Data sourced from ClinicalTrials.gov (NCT03214081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.