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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032495
Receipt No. R000037049
Scientific Title Study of the improvement effect of the Maintenance treatment of Vonoprazan and Esomeprazole on symptoms in patients with gastro-esophageal reflux disease (GERD)
Date of disclosure of the study information 2018/05/14
Last modified on 2018/05/07

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Basic information
Public title Study of the improvement effect of the Maintenance treatment of Vonoprazan and Esomeprazole on symptoms in patients with gastro-esophageal reflux disease (GERD)
Acronym Study of the improvement effect of the Maintenance treatment of Vonoprazan and Esomeprazole on symptoms in patients with gastro-esophageal reflux disease (GERD)
Scientific Title Study of the improvement effect of the Maintenance treatment of Vonoprazan and Esomeprazole on symptoms in patients with gastro-esophageal reflux disease (GERD)
Scientific Title:Acronym Study of the improvement effect of the Maintenance treatment of Vonoprazan and Esomeprazole on symptoms in patients with gastro-esophageal reflux disease (GERD)
Region
Japan

Condition
Condition gastro-esophageal reflux disease (GERD)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to administer Vonoprazan 20 mg once a day for patients with gastroesophageal reflux disease for 2 weeks as an initial treatment and then to administer Vonoprazan 10 mg once a day or Esomeprazole 20 mg once a day as maintenance therapy and to clinically evaluate the clinical effect after 2 weeks The GerdQ score which is a patient self-entry questionnaire as an index is compared as an indicator.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the change in GerdQ total score before and 2,4 weeks after treatment with Vonoprazan and Esomeprazole
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Vonoprazan 20mg orally once a day for two weeks,continued by Vonoprazan 10mg orally once a day for two weeks
Interventions/Control_2 Vonoprazan 20mg orally once a day for two weeks,continued by Esomeprazole 20mg orally once a day for two weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who have freely given written consent to participating in the study after receiving a full explanation (written and oral) of the study.
2) Patients who had 8 or more of GerdQ score before the registration
3)Patients who were diagnosed with GERD
Key exclusion criteria 1)Patients with warning signs such as
vomiting, gastrointestinal bleeding (including findings of hematemesis, melena, and anemia),and sudden weight loss
2)Patients with a confirmed, or suspected, malignant lesion
3)Patients with a history of gastrointestinal resection or vagotomy
4)The patient with Irritable Bowel Syndrome (IBS)
5)Patients whose participation in this study would be contraindicated due to
complications such as serious hepatic
disease, renal disease, or cardiac disease.
6)Women who are pregnant or who may possibly be pregnant, and lactating mothers
7)treated with atazanavir sulfate, Rilpivirine Hydrochloride
8)Other patients whom the investigator
considers unsuitable for admission to the
study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Nagaike
Organization Suita municipal hospital
Division name Gastroenterology
Zip code
Address 2-13-20, Katayamacho, Suita, Osaka, 564-0082, Japan
TEL 06-6387-3311
Email nagaike7477@mhp.suita.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Nagaike
Organization Suita municipal hospital
Division name Gastroenterology
Zip code
Address 2-13-20, Katayamacho, Suita, Osaka, 564-0082, Japan
TEL 06-6387-3311
Homepage URL
Email nagaike7477@mhp.suita.osaka.jp

Sponsor
Institute Suita municipal hospital
Institute
Department

Funding Source
Organization Suita municipal hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 07 Day
Last modified on
2018 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037049

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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