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Special dr ug Use Surveillance of Takecab for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs:Long-term Use

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ClinicalTrials.gov Identifier: NCT03214198
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Description
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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 NSAIDs.

Condition or disease Intervention/treatment
A History of 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 NSAIDs.

The study will enroll approximately 1000 patients.

• Vonoprazan 10 mg

This multi-center trial will be conducted in Japan.


Study Design
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Study Type : Observational
Estimated Enrollment : 1000 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 Non-steroidal Anti-inflammatory Drugs:Long-term Use"
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Vonoprazan 10 mg
The usual adult dosage is 10 mg of Vonoprazan administered orally once daily. Participants will receive interventions as part of routine medical care.
 Drug: Vonoprazan
Vonoprazan tablets
Other Names:
  • Takecab tablets
  • TAK-438


Outcome Measures
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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 [ 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: patient 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 NSAIDs, etc.). Reporting data will be total percentage of participants with gastric or duodenal ulcers, or hemorrhagic lesions.


Eligibility Criteria
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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 NSAIDs 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
Contacts and Locations
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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): NCT03214198


Contacts
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Contact: Takeda Study Registratio Call Center +1-877-825-3327 medicalinformation@tpna.com

Locations
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Japan
Takeda Selected Site Recruiting
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Chair: Postmarketing Group Manager Takeda
More Information
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03214198     History of Changes
Other Study ID Numbers: Vonoprazan-5005
JapicCTI-163436 ( Registry Identifier: JapicCTI )
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
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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Ulcer
Recurrence
Duodenal Ulcer
Pathologic Processes
Disease Attributes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Stomach Diseases
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents