UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022166 |
|---|---|
| Receipt number | R000025540 |
| Scientific Title | Study of symptom improvement effect of gastric acid suppressive drugs in reflux esophagitis patients -a randomized comparative study of vonoprazan vs esomeprazole - |
| Date of disclosure of the study information | 2016/05/06 |
| Last modified on | 2017/11/02 12:24:23 |
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Basic information
Public title
Study of symptom improvement effect of gastric acid suppressive drugs in reflux esophagitis patients
-a randomized comparative study of vonoprazan vs esomeprazole -
Acronym
Study of symptom improvement effect of vonoprazan and esomeprazole in reflux esophagitis patients
Scientific Title
Study of symptom improvement effect of gastric acid suppressive drugs in reflux esophagitis patients
-a randomized comparative study of vonoprazan vs esomeprazole -
Scientific Title:Acronym
Study of symptom improvement effect of vonoprazan and esomeprazole in reflux esophagitis patients
Region
| Japan |
Condition
Condition
Reflux esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the clinical effect of vonoprazan 20mg/day vs. esomeprazole 20mg/day after 4 weeks of treatment in patients with reflux esophagitis using Gerd Q score of heartburn and acid regurgitation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gerd Q total score of heartburn and acid regurgitation
Key secondary outcomes
1.Gerd Q each score of heartburn and acid regurgitation
2.Gerd Q each score of epigastralgia, nausea and vomiting
3.Evaluation of treatment response with Gerd Q
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 4 weeks
Interventions/Control_2
Esomeprazole 20mg orally once a day for 4 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 aged 20 years or older at the time of providing informed consent
2.Patients who are diagnosed as having reflux esophagitis by physician
3.Patients who check 2-3days or 4-7 days a week in GerdQ Q1 and/or Q2
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 confirmed or suspected malignant lesion
3.Patients with a history of gastrointestinal resection or vagotomy
4.Patients in Irritable Bowel Syndrome
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.Other patients whom the investigator considers unsuitable for admission to the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Maeda |
Organization
Sapporo-kosei General Hospital
Division name
Department of Gastroenterology
Zip code
Address
5, Higashi 8-chome, Kita-3jo, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
+81-11-261-5331
sat.maeda@ja-hokkaidoukouseiren.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Terakado |
Organization
Sapporo-kosei General Hospital
Division name
Department of Gastroenterology
Zip code
Address
5, Higashi 8-chome, Kita-3jo, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
+81-11-261-5331
Homepage URL
yohei540525@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology, Sapporo-kosei General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2016 | Year | 05 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 09 | 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
| 2016 | Year | 05 | Month | 02 | Day |
Last modified on
| 2017 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025540
