Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"

Completed

• Conditions: Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis
• Interventions: Drug: Vonoprazan

• Registration Number: NCT03214952
• Lead Sponsor: Takeda

Brief 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.

Detailed Description

The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat patients who have gastric ulcer, duodenal ulcer, and reflux esophagitis.

This survey will look at the safety and effectiveness of vonoprazan in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting. The survey will enroll approximately 3000 participants.

- Vonoprazan 20 mg

This multi-center survey will be conducted in Japan.

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2017-07-09
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-12
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Results First Submitted: 2019-10-29
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-21
• Last Update Submitted: 2019-11-21
• Results First Posted: 2019-12-12
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3183

Inclusion Criteria

• Participants with gastric ulcer, duodenal ulcer, and reflux esophagitis

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vonoprazan 20 mg	Vonoprazan	The usual adult dosage for oral use is 20 mg of vonoprazan administered orally once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use was administered for a total of 4 weeks of treatment, and if that dosing proved insufficient, the administration may have been extended, but for no longer than 8 weeks of treatment. Participants received vonoprazan as part of a routine medical care.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Gastric Ulcer Who Had One or More Adverse Drug Reactions	Up to 8 weeks	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 the administered drug.
Percentage of Participants With Duodenal Ulcer Who Had One or More Adverse Drug Reactions	Up to 6 weeks	An 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 the administered drug.
Percentage of Participants With Reflux Esophagitis Who Had One or More Adverse Drug Reactions	Up to 8 weeks	An 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 the administered drug.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved	Baseline and at the end of the survey (up to 6 weeks)	Percentage of participants who treated for duodenal ulcer and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved".
Endoscopic Cure Rate in Participants With Gastric Ulcer	Up to 8 weeks	Endoscopic cure rate was defined as a percentage of participants treated for gastric ulcer who classified as Scarring stage at the end of survey per Sakita-Miwa Classification. Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2.
Endoscopic Cure Rate in Participants With Duodenal Ulcer	Up to 6 weeks	Endoscopic cure rate was defined as a percentage of participants treated for duodenal ulcer who classified as Scarring stage at the end of survey per Sakita-Miwa Classification. Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2.
Endoscopic Cure Rate in Participants With Reflux Esophagitis	Up to 8 weeks	Endoscopic cure rate was defined as a percentage of participants who treated for reflux esophagitis and met the criteria of Grade N or M in the modified Los Angeles (LA) classification at the end of survey. Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity.
Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved	Baseline and at the end of the survey (up to 8 weeks)	Percentage of participants who treated for gastric ulcer and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved".
Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved	Baseline and at the end of the survey (up to 8 weeks)	Percentage of participants who treated for reflux esophagitis and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved".

Trial Locations

Locations (1)

Takeda Selected Site; 🇯🇵 Tokyo, Japan