N/A
N=3,183
Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"
Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis
Bottom Line
View on ClinicalTrials.gov: NCT03214952 ↗Enrolled (actual)
3,183
Serious AEs
0.6%
Results posted
Dec 2019
Primary outcome: Primary: Percentage of Participants With Gastric Ulcer Who Had One or More Adverse Drug Reactions — 1.00 Percentage of Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Vonoprazan (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Gastric Ulcer Who Had One or More Adverse Drug Reactions |
1.00 | — |
| PRIMARY Percentage of Participants With Duodenal Ulcer Who Had One or More Adverse Drug Reactions |
1.21 | — |
| PRIMARY Percentage of Participants With Reflux Esophagitis Who Had One or More Adverse Drug Reactions |
0.78 | — |
| SECONDARY Endoscopic Cure Rate in Participants With Gastric Ulcer |
78.72 | — |
| SECONDARY Endoscopic Cure Rate in Participants With Duodenal Ulcer |
88.46 | — |
| SECONDARY Endoscopic Cure Rate in Participants With Reflux Esophagitis |
65.04 | — |
| SECONDARY Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved |
96.68; 96.86; 96.09; 97.08; 98.78; 97.62 | — |
| SECONDARY Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved |
96.94; 97.22; 95.65; 98.78; 98.58; 100.00 | — |
| SECONDARY Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved |
96.20; 94.33; 93.22; 92.37; 95.79; 96.72 | — |
Summary
The purpose of this survey is to evaluate the safety and effectiveness of vonoprazan tablets in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting.
Eligibility Criteria
Inclusion Criteria
- Participants with gastric ulcer, duodenal ulcer, and reflux esophagitis
Exclusion Criteria
- Participants with previous history of hypersensitivity to ingredients in Takecab tablets
- Participants taking atazanavir sulfate or rilpivirine hydrochloride
- Participants meeting the criteria of scarring stage (S1, S2) of endoscopic classification defined by Sakita and Miwa at the start of the treatment with Takecab tablets, in the case that the target disease is gastric ulcer or duodenal ulcer
- Participants meeting the criteria of Grade N or Grade M of Los Angeles classification (Hoshihara's modification) at the start of the treatment with Takecab tablets, in the case that the target disease is reflux esophagitis.
Data sourced from ClinicalTrials.gov (NCT03214952). 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.