UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004769 |
|---|---|
| Receipt number | R000005678 |
| Scientific Title | study of effect of H2RA for the epigastric symptoms |
| Date of disclosure of the study information | 2011/12/22 |
| Last modified on | 2017/06/22 10:53:48 |
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Basic information
Public title
study of effect of H2RA for the epigastric symptoms
Acronym
study of effect of H2RA for the epigastric symptoms
Scientific Title
study of effect of H2RA for the epigastric symptoms
Scientific Title:Acronym
study of effect of H2RA for the epigastric symptoms
Region
| Japan |
Condition
Condition
functional dyspepsia and gastroesophageal reflux diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An ideal drug therapy to the disease related to the acid in the stomach such as gastroesophageal reflux diseases causes a prompt effect with the improvement of the symptom. Our study uses and examines QOL questionnaire (Japanese version GSRS: three item of the acid backflow, stomachache, and dyspepsia nine questions). A prompt production of effect in the peroral administration of Roxatidine 75mg is researched by examining in an interview and evaluating four points "Before it takes it", "One hour later of taking", "Three hours later of taking", and "Six hours later of taking".
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
epigastric symptoms
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Roxatidine 75mg
Interventions/Control_2
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
The patient with epigastric symptoms before endoscopy.
Key exclusion criteria
1)Patient who has ulcer [**]
2)Patient who receives operation of gut excision and vagectomy
3)Patient who has diseases of serious renal damage, hepatic toxicit, and blood trouble, etc.
4)Patient who has malignant tumor
5)Patient who has possibility of pregnant woman and pregnancy
6)Patient who has change in dosage taking NSAID and gut movement activating medicine, and before and after experimental drug taking
7)Patient who is administering antsecratory medcines such as PPI and H2RA
(H2RA needs the doing taking medicine period for PPI for two weeks or more for one week or more for the patient who had been administered before. )
8)Patient who has allergic history for experimental roxatidine
9)Patient who assumes judgment from doctor when it is improper as object of this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nakajima |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
045-787-2640
nakajima-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Inamori |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
045-787-2640
Homepage URL
inamorim@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 12 | Month | 22 | 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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | 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
| 2010 | Year | 12 | Month | 21 | Day |
Last modified on
| 2017 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005678
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
