UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003013
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email kinosita@med.shimane-u.ac.jp

Sponsor
Institute Yoshikazu Kinoshita
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003654

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.