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Special Drug Use Surveillance of Takecab for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"

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: NCT03214081
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of long-term administration of Vonoprazan tablets (Takecab tablets) when used as maintenance therapy for reflux esophagitis in routine clinical settings.

Condition or disease Intervention/treatment
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 reflux esophagitis.

This study will look at the safety and efficacy of long-term administration of Vonoprazan tablets (Takecab tablets) when used as maintenance therapy for reflux esophagitis in routine clinical settings.

The study will enroll approximately 1000 patients.

• Vonoprazan 10 mg/20 mg

This multi-center trial will be conducted in Japan.


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Study Type : Observational
Actual Enrollment : 1237 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Drug Use Surveillance of Takecab Tablets for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Group/Cohort Intervention/treatment
Vonoprazan 10 mg/20 mg
The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily; however, if the efficacy is inadequate, the dosage may be increased up to 20 mg once daily. 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 [ 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) as maintenance therapy up to 12 months after the start of treatment (or at the time of treatment discontinuation).


Secondary Outcome Measures :
  1. Endoscopic relapse rates [ Time Frame: At the end of treatment (up to 12 months) ]
    Endoscopic relapse rates (percentages of patients meeting the criteria of Grade A to D according to the Los Angeles classification) will be tabulated in patients for whom endoscopic findings at the start of treatment with Vonoprazan tablets (Takecab), during treatment, and 12 months after the start of treatment (or at the time of treatment discontinuation) administered as maintenance therapy.

  2. Changes in number of participants with the severity of subjective symptoms [ Time Frame: At the start of treatment (Week 0) and the end of treatment (up to 12 months) ]
    Changes in number of participants with the severity of subjective symptoms will be tabulated in patients for whom the severity of subjective symptoms at the start of treatment with Vonoprazan tablets (Takecab), and at each observation time point after treatment administered as maintenance therapy.



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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 reflux esophagitis and received dose of Takecab/Vonoprazan in the routine medical care.
Criteria

Inclusion Criteria:

  • Participants who require maintenance therapy for relapsed/recurrent reflux esophagitis

Exclusion Criteria:

  • Participants meeting the criteria of grade A to D according to the Los Angeles classification (Hoshihara's modification), by means of endoscopy at the initiation of maintenance therapy with Takecab tablets
  • Participants with a 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): NCT03214081


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: NCT03214081     History of Changes
Other Study ID Numbers: Vonoprazan-5003
JapicCTI-163202 ( Registry Identifier: JapicCTI )
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 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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Gastroesophageal Reflux
Esophagitis
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases