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Trial record 62 of 921 for:    tablet | Japan

Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"

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ClinicalTrials.gov Identifier: NCT03219723
Recruitment Status : Completed
First Posted : July 17, 2017
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date July 9, 2017
First Posted Date July 17, 2017
Results First Submitted Date April 27, 2018
Results First Posted Date March 22, 2019
Last Update Posted Date March 22, 2019
Actual Study Start Date September 1, 2015
Actual Primary Completion Date April 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 25, 2018)
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).
Original Primary Outcome Measures
 (submitted: July 13, 2017)
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 is 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).
Change History Complete list of historical versions of study NCT03219723 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 25, 2018)
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).
Original Secondary Outcome Measures
 (submitted: July 13, 2017)
H. Pylori Eradication Rate [ Time Frame: 7 days + 2 months ]
In participants who are determined as achieving H. pylori eradication, the proportion of patients negative for H. pylori (eradication rates) will be tabulated by first-line eradication and second-line eradication. Timeframe is 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"
Official Title Drug Use Surveillance of Takecab Tablets "Supplement to Helicobacter Pylori Eradication"
Brief Summary The purpose of this study is to evaluate the safety and efficacy on participants receiving first-line eradication and second-line eradication including vonoprazan (Takecab) tablets (triple therapy) in the routine clinical setting.
Detailed Description

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.

First-line eradication

  • 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.

Second-line eradication

  • Vonoprazan 20 mg
  • Amoxicillin hydrate 750 mg
  • metronidazole 250 mg

This multi-center trial will be conducted in Japan.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population will consist of participants receiving first-line eradication and second-line eradication including Takecab tablets (triple therapy) in the routine medical care.
Condition Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other
Intervention
  • Drug: Vonoprazan
    Vonoprazan tablets
    Other Names:
    • Takecab tablets
    • TAK-438
  • Drug: Amoxicillin hydrate
    Amoxicillin hydrate (potency)
  • Drug: Clarithromycin
    Clarithromycin (potency)
  • Drug: Metronidazole
    Metronidazole
Study Groups/Cohorts 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.
Interventions:
  • Drug: Vonoprazan
  • Drug: Amoxicillin hydrate
  • Drug: Clarithromycin
  • Drug: Metronidazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 25, 2018)
560
Original Actual Enrollment
 (submitted: July 13, 2017)
500
Actual Study Completion Date April 30, 2017
Actual Primary Completion Date April 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participants receiving H. pylori eradication treatment for the first time
  • Participants for whom H. pylori eradication with Takecab tablets or proton pump inhibitor + amoxicillin + clarithromycin was found unsuccessful and who will receive eradication treatment with amoxicillin and metronidazole

Exclusion Criteria:

  • Participants with previous history of hypersensitivity to ingredients in Takecab tablets
  • Participants taking atazanavir sulfate or rilpivirine hydrochloride
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03219723
Other Study ID Numbers Vonoprazan-5002
JapicCTI-153003 ( Registry Identifier: JapicCTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Takeda
Study Sponsor Takeda
Collaborators Not Provided
Investigators
Study Director: Study Director Takeda
PRS Account Takeda
Verification Date December 2018