Special dr ug Use Surveillance of Takecab for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs:Long-term Use
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|ClinicalTrials.gov Identifier: NCT03214198|
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment|
|A History of Gastric or Duodenal Ulcers||Drug: Vonoprazan|
The drug being tested in this study is called Vonoprazan (Takecab). Vonoprazan is being tested to treat people who have gastric or duodenal ulcers.
This study will look at the safety and efficacy of long-term administration of Vonoprazan tablets (Takecab tablets) for up to 12 months in the routine clinical setting in patients receiving NSAIDs.
The study will enroll approximately 1000 patients.
• Vonoprazan 10 mg
This multi-center trial will be conducted in Japan.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Special Drug Use Surveillance of Takecab Tablets for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs:Long-term Use"|
|Actual Study Start Date :||September 1, 2016|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||April 30, 2020|
Vonoprazan 10 mg
The usual adult dosage is 10 mg of Vonoprazan administered orally 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) up to 12 months after the start of treatment (or at the time of treatment discontinuation).
- Percentage of participants with gastric or duodenal ulcers or hemorrhagic [ Time Frame: Up to 12 months ]The presence or absence of onset of gastric or duodenal ulcers or hemorrhagic lesions will be tabulated. The presence or absence of onset of gastric or duodenal ulcers or hemorrhagic lesions will be tabulated by stratification variables: patient background factors (sex, age, the presence or absence of Helicobacter pylori infection, etc.) and treatment regimens (details of the administration of Takecab tablets, details of the administration of NSAIDs, etc.). Reporting data will be total percentage of participants with gastric or duodenal ulcers, or hemorrhagic lesions.
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): NCT03214198
|Contact: Takeda Study Registratio Call Centeremail@example.com|
|Takeda Selected Site||Recruiting|
|Study Chair:||Postmarketing Group Manager||Takeda|