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
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Condition or disease | Intervention/treatment |
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A History of Gastric or Duodenal Ulcers | Drug: Vonoprazan |
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 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 |
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.
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Drug: Vonoprazan
Vonoprazan tablets
Other Names:
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- 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).
- 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.

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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 |
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

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
Contact: Takeda Study Registratio Call Center | +1-877-825-3327 | medicalinformation@tpna.com |
Japan | |
Takeda Selected Site | Recruiting |
Tokyo, Japan |
Study Chair: | Postmarketing Group Manager | Takeda |
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 |
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 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 |