Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"
|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: NCT03219723|
Recruitment Status : Completed
First Posted : July 17, 2017
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
|Condition or disease||Intervention/treatment|
|Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other||Drug: Vonoprazan Drug: Amoxicillin hydrate Drug: Clarithromycin Drug: Metronidazole|
The drug being tested in this study is called Vonoprazan (Takecab). Vonoprazan is being tested to treat people who have gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, stomach following endoscopic treatment of early gastric cancer, or H. pylori gastritis. This study will look at the presence or absence of new concerns regarding the safety of triple therapy with Vonoprazan tablets, amoxicillin, and clarithromycin (first-line eradication) and triple therapy with Vonoprazan tablets, amoxicillin, and metronidazole (second-line eradication) for supplemental Helicobacter pylori (H. pylori) eradication in the routine clinical setting. The study will enroll approximately 500 patients.
- Vonoprazan 20 mg / Proton pump inhibitor
- Amoxicillin hydrate 750 mg
- Clarithromycin 200 mg
If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin has been unsuccessful.
- Vonoprazan 20 mg
- Amoxicillin hydrate 750 mg
- metronidazole 250 mg
This multi-center trial will be conducted in Japan.
|Study Type :||Observational|
|Actual Enrollment :||560 participants|
|Official Title:||Drug Use Surveillance of Takecab Tablets "Supplement to Helicobacter Pylori Eradication"|
|Actual Study Start Date :||September 1, 2015|
|Actual Primary Completion Date :||April 30, 2017|
|Actual Study Completion Date :||April 30, 2017|
Vonoprazan 20 mg
For adults, the following three-drug regimen will be administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin may be increased as clinically warranted. However, dosage should not exceed 400 mg (potency)/dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin has been unsuccessful, as an alternative treatment, the following three drugs will be administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants will receive interventions as part of routine medical care.
Drug: Amoxicillin hydrate
Amoxicillin hydrate (potency)
- Percentage of Participants Who Had One or More Adverse Drug Reactions [ Time Frame: Up to 7 days and 2 months ]Adverse drug reaction refers to adverse events related to administered drug. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).
- H. Pylori Eradication Rate [ Time Frame: 7 days + 2 months ]In participants who were determined as achieving H. pylori eradication, the percentage of participants negative for H. pylori (eradication rates) was tabulated by first-line eradication and second-line eradication. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).
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): NCT03219723
|Takeda Selected Site|
|Study Director:||Study Director||Takeda|