Special Drug Use Surveillance of Takecab for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
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|ClinicalTrials.gov Identifier: NCT03214081|
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment|
|Reflux Esophagitis||Drug: Vonoprazan|
The drug being tested in this study is called Vonoprazan (Takecab). Vonoprazan is being tested to treat people who have reflux esophagitis.
This study will look at the safety and efficacy of long-term administration of Vonoprazan tablets (Takecab tablets) when used as maintenance therapy for reflux esophagitis in routine clinical settings.
The study will enroll approximately 1000 patients.
• Vonoprazan 10 mg/20 mg
This multi-center trial will be conducted in Japan.
|Study Type :||Observational|
|Actual Enrollment :||1237 participants|
|Official Title:||Special Drug Use Surveillance of Takecab Tablets for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"|
|Actual Study Start Date :||March 1, 2016|
|Actual Primary Completion Date :||August 31, 2018|
|Actual Study Completion Date :||August 31, 2018|
Vonoprazan 10 mg/20 mg
The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily; however, if the efficacy is inadequate, the dosage may be increased up to 20 mg once daily. Participants will receive interventions as part of routine medical care.
- Percentage of participants who had one or more adverse drug reactions [ Time Frame: Up to 12 months ]Adverse drug reaction refers to adverse events related to administered drug. Time frame is defined the duration from the start of treatment with Vonoprazan tablets (Takecab) as maintenance therapy up to 12 months after the start of treatment (or at the time of treatment discontinuation).
- Endoscopic relapse rates [ Time Frame: At the end of treatment (up to 12 months) ]Endoscopic relapse rates (percentages of patients meeting the criteria of Grade A to D according to the Los Angeles classification) will be tabulated in patients for whom endoscopic findings at the start of treatment with Vonoprazan tablets (Takecab), during treatment, and 12 months after the start of treatment (or at the time of treatment discontinuation) administered as maintenance therapy.
- Changes in number of participants with the severity of subjective symptoms [ Time Frame: At the start of treatment (Week 0) and the end of treatment (up to 12 months) ]Changes in number of participants with the severity of subjective symptoms will be tabulated in patients for whom the severity of subjective symptoms at the start of treatment with Vonoprazan tablets (Takecab), and at each observation time point after treatment administered as maintenance therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03214081
|Takeda Selected Site|
|Study Chair:||Postmarketing Group Manager||Takeda|