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Trial record 3 of 6 for:    "Thrombocytopenic Purpura, Autoimmune" | "Amoxicillin"

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

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.

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

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.


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Study Type : Observational
Actual Enrollment : 560 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
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: Vonoprazan
Vonoprazan tablets
Other Names:
  • Takecab tablets
  • TAK-438

Drug: Amoxicillin hydrate
Amoxicillin hydrate (potency)

Drug: Clarithromycin
Clarithromycin (potency)

Drug: Metronidazole
Metronidazole




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Locations
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Japan
Takeda Selected Site
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Study Protocol  [PDF] February 23, 2018
Statistical Analysis Plan  [PDF] November 8, 2017


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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03219723     History of Changes
Other Study ID Numbers: Vonoprazan-5002
JapicCTI-153003 ( Registry Identifier: JapicCTI )
First Posted: July 17, 2017    Key Record Dates
Results First Posted: March 22, 2019
Last Update Posted: March 22, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amoxicillin
Lymphoma, B-Cell, Marginal Zone
Gastritis
Duodenal Ulcer
Stomach Ulcer
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma