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Trial record 35 of 914 for:    tablet | Japan

Drug Use Surveillance of Takecab for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03214952
Recruitment Status : Completed
First Posted : July 12, 2017
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of vonoprazan tablets (Takecab tablets) in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting.

Condition or disease Intervention/treatment
Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis 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 ulcer, duodenal ulcer, and reflux esophagitis.

This study will look at the safety and efficacy of Vonoprazan in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting.

The study will enroll approximately 3000 patients.

• Vonoprazan 20 mg

This multi-center trial will be conducted in Japan.


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Study Type : Observational
Actual Enrollment : 3183 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Use Surveillance of Takecab Tablets for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Group/Cohort Intervention/treatment
Vonoprazan 20 mg
The usual adult dosage for oral use is 20 mg of Vonoprazan administered once daily. An 8-week treatment for gastric ulcer and a 6-week treatment for duodenal ulcer. For reflux esophagitis, the usual adult dosage for oral use is administered for a total of 4 weeks of treatment, and if that dosing proves insufficient, the administration may be extended, but for no longer than 8 weeks of treatment. Participants will receive interventions as part of routine medical care.
Drug: Vonoprazan
Vonoprazan tablets
Other Names:
  • Takecab tablets
  • TAK-438




Primary Outcome Measures :
  1. Percentage of participants who had one or more adverse drug reactions in patients with gastric ulcer and reflux esophagitis [ Time Frame: Up to 8 Weeks ]
    Adverse drug reaction refers to adverse events related to administered drug.

  2. Percentage of participants who had one or more adverse drug reactions in patients with duodenal ulcer [ Time Frame: Up to 6 Weeks ]
    Adverse drug reaction refers to adverse events related to administered drug.


Secondary Outcome Measures :
  1. Endoscopic cure rates [ Time Frame: At the start of treatment (Week 0), and at the end of surveillance [up to 8 Weeks (gastric ulcer and reflux esophagitis) or 6 Weeks (duodenal ulcer)] ]
    Endoscopic cure rates will be tabulated by target disease in patients for whom endoscopic findings at the start of treatment with Vonoprazan tablets (Takecab) and at the end of surveillance are described.

  2. Percentage of participants with improvement rates of subjective symptoms [ Time Frame: At the start of treatment (Week 0), week 2, week 4, and at the end of surveillance [up to 8 Weeks (gastric ulcer and reflux esophagitis) or 6 Weeks (duodenal ulcer)] ]
    Improvement rates of subjective symptoms will be tabulated by target disease in patients for whom the degree of subjective symptoms from the start of treatment with Vonoprazan tablets (Takecab) to the end of surveillance are described. Reporting data will be total percentage of participants who have subjective symptoms related to gastric ulcer, duodenal ulcer, and reflux esophagitis.



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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 ulcer, duodenal ulcer, and reflux esophagitisand received dose of Takecab/Vonoprazan in the routine clinical setting.
Criteria

Inclusion Criteria:

  • Participants with gastric ulcer, duodenal ulcer, and reflux esophagitis

Exclusion Criteria:

  • Participants with previous history of hypersensitivity to ingredients in Takecab tablets
  • Participants taking atazanavir sulfate or rilpivirine hydrochloride
  • Participants meeting the criteria of scarring stage (S1, S2) of endoscopic classification defined by Sakita and Miwa at the start of the treatment with Takecab tablets, in the case that the target disease is gastric ulcer or duodenal ulcer
  • Participants meeting the criteria of Grade N or Grade M of Los Angeles classification (Hoshihara's modification) at the start of the treatment with Takecab tablets, in the case that the target disease is reflux esophagitis.

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): NCT03214952


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

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03214952     History of Changes
Other Study ID Numbers: Vonoprazan-5001
JapicCTI-163177 ( Registry Identifier: JapicCTI )
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 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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Ulcer
Gastroesophageal Reflux
Esophagitis
Stomach Ulcer
Duodenal Ulcer
Esophagitis, Peptic
Pathologic Processes
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases