Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"

Reflux Esophagitis Clinical Trial

Official title:

Special Drug Use Surveillance of Takecab Tablets for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03214081
• Other study ID #: Vonoprazan-5003
• Secondary ID: JapicCTI-163202
• Status: Completed
• Start date: March 1, 2016
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1237
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• Gastroesophageal Reflux
• Reflux Esophagitis

Intervention

Drug:
• Vonoprazan
Vonoprazan tablets

Locations

Country	Name	City	State
Japan	Takeda Selected Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 months
Secondary	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.	From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), up to 12 months
Secondary	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.	Baseline, Month 6 and at Month 12
Secondary	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.	Baseline, Month 6 and at Month 12
Secondary	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.	Baseline, Month 6 and at Month 12
Secondary	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.	Baseline, Month 6 and at Month 12
Secondary	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.	Baseline, Month 6 and at Month 12
Secondary	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.	Baseline, Month 6 and at Month 12
Secondary	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.	Baseline, Month 6 and at Month 12
Secondary	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.	Baseline, Month 6 and at Month 12
Secondary	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.	Baseline, Month 6 and at Month 12
Secondary	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.	Baseline, Month 6 and at Month 12