UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003013 |
|---|---|
| Receipt number | R000003654 |
| Scientific Title | Study investigating the effect of irsogladine maleate on PPI-resistant GERD |
| Date of disclosure of the study information | 2010/02/01 |
| Last modified on | 2010/08/12 09:44:13 |
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Basic information
Public title
Study investigating the effect of irsogladine maleate on PPI-resistant GERD
Acronym
irsogladine on GERD
Scientific Title
Study investigating the effect of irsogladine maleate on PPI-resistant GERD
Scientific Title:Acronym
irsogladine on GERD
Region
| Japan |
Condition
Condition
GERD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of co-administration of irsogladine to patients with PPI-resistant GERD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical symptoms and QOL evaluated by questionaires.
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
co-administration of irsogladine
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
patients with sGERD whose mean QOLRAD-J score are less than 5
Key exclusion criteria
Cases taking H2RA,mucosa defencing agents,mucoprotective agents.
Cases who took PPI in the recent 2 weeks.
Cases taking NSAIDs,salicylate, antimuscarinic agents,prokinetics, PG.
Cases whose inclusion is considered to be inappropriate by the attending physicians.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University School of Medicine
Division name
Department of Medicine II
Zip code
Address
89-1, Enya, Izumo-shi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University
Division name
Department of Medicine II
Zip code
Address
TEL
Homepage URL
kinosita@med.shimane-u.ac.jp
Sponsor or person
Institute
Yoshikazu Kinoshita
Institute
Department
Personal name
Funding Source
Organization
Department of MeidicneII
Shimane University
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
| 2010 | Year | 02 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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 | 01 | Month | 12 | Day |
Last modified on
| 2010 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003654
