UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032495 |
|---|---|
| Receipt number | 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 16:19:21 |
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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
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
nagaike7477@mhp.suita.osaka.jp
Sponsor or person
Institute
Suita municipal hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037049
