UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008551 |
|---|---|
| Receipt number | R000010051 |
| Scientific Title | A study on relapse of the symptom comparing 2 weeks and 8 weeks of treatment period in GERD patients using the newly established GerdQ questionnaires |
| Date of disclosure of the study information | 2012/07/30 |
| Last modified on | 2016/07/30 12:59:51 |
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Basic information
Public title
A study on relapse of the symptom comparing 2 weeks and 8 weeks of treatment period in GERD patients using the newly established GerdQ questionnaires
Acronym
GERD treatment period study
Scientific Title
A study on relapse of the symptom comparing 2 weeks and 8 weeks of treatment period in GERD patients using the newly established GerdQ questionnaires
Scientific Title:Acronym
GERD treatment period study
Region
| Japan |
Condition
Condition
GERD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the relapse of GER symptoms in relation with the length of the treatment in the patients with reflux esophagitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
length of the GER symptom free periods after the treatment
Key secondary outcomes
1) factors affecting the relapse of GERD
2) difference of GER symptoms between before and after the 2 week treatment and the rates of the disappearance of GER symptoms
3) the severity of GER symptoms in case of the relapse
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
no additional treatment
Interventions/Control_2
Additional treatment of esomeprazole for 6 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
LA grade A or B diagnosed by esophagoscopy within 6 months
Having GER symptoms
Disappearance of GER symptoms after the treatment by esomeprazole (20 mg/day for 2 weeks) by GerdQ questionnaire
Key exclusion criteria
Patiets with the history of gastric surgeries
Patients with alarm symptoms such as vomiting, GI bleeding, rapid body weight loss
Patients of alcohol or drug dependence
Patients with severe endocrine problems
Patients with severe injuries of heart, liver, kidney or bone marrow functions
Patients with allergy against the test drugs
Patients with pregnancy, possible pregnancy or breast feeding, or hope of pregnancy during the test period
Patients whom the doctor decide as not proper for the study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Matsushima |
Organization
Tokai University Tokyo Hospital
Division name
Internal Medicine (Gastroenterology)
Zip code
Address
1-2-5 Yoyogi, Shibuya-ku, Tokyo 151-0053, Japan
TEL
03-3370-2321
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Matsushima |
Organization
Tokai University Tokyo Hospital
Division name
Internal Medicine (Gastroenterology)
Zip code
Address
1-2-5 Yoyogi, Shibuya-ku, Tokyo 151-0053, Japan
TEL
03-3370-2321
Homepage URL
Sponsor or person
Institute
Tokai University School of Medicine
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
Showa University Hospital
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
東海大学東京病院(東京都) Tokai University Tokyo Hospital
東海大学医学部付属病院(神奈川県) Tokai University Hospital
昭和大学病院（東京都）Showa University Hospital
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 27 | Day |
Last modified on
| 2016 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010051
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| Registered date | File name |
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| Registered date | File name |
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