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Special Drug Use Surveillance of Takecab for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"

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ClinicalTrials.gov Identifier: NCT03214094
Recruitment Status : Active, not recruiting
First Posted : July 11, 2017
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to investigate 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.

Condition or disease Intervention/treatment
Gastric or Duodenal Ulcers Drug: Vonoprazan

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



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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 with a diagnosis of gastric or duodenal ulcers and during low-dose aspirin administration in the routine medical care.
Criteria

Inclusion Criteria:

  • Participants with a history of gastric or duodenal ulcers

Exclusion Criteria:

  • Participants with gastric or duodenal ulcer at the start of administration of Takecab tablets
  • Participants with active upper gastrointestinal hemorrhage at the start of administration of Takecab tablets
  • 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): NCT03214094


Locations
Japan
Takeda Selected Site
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03214094     History of Changes
Other Study ID Numbers: Vonoprazan-5004
JapicCTI-163435 ( Registry Identifier: JapicCTI )
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ulcer
Recurrence
Duodenal Ulcer
Pathologic Processes
Disease Attributes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics