Special Drug Use Surveillance of Takecab for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03214094|
Recruitment Status : Active, not recruiting
First Posted : July 11, 2017
Last Update Posted : July 16, 2018
|Condition or disease||Intervention/treatment|
|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 low-dose aspirin.
The study will enroll approximately 1000 patients.
• Vonoprazan 10 mg
This multi-center trial will be conducted in Japan.
|Study Type :||Observational|
|Actual Enrollment :||1119 participants|
|Official Title:||Special Drug Use Surveillance of Takecab Tablets for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"|
|Actual Study Start Date :||September 1, 2016|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||August 31, 2019|
Vonoprazan 10 mg
The usual adult dosage for oral use is 10 mg of Vonoprazan administered 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 lesions after the start of administration of Takecab tablets [ 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: participants 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 low-dose aspirin, 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): NCT03214094
|Takeda Selected Site|
|Study Chair:||Postmarketing Group Manager||Takeda|