UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005203
Receipt No. R000006180
Scientific Title gastroesophageal reflux disease in children with episodes of recurrent wheeze
Date of disclosure of the study information 2011/03/08
Last modified on 2011/03/06

* 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 gastroesophageal reflux disease in children with episodes of recurrent wheeze
Acronym gastroesophageal reflux disease in children with episodes of recurrent wheeze
Scientific Title gastroesophageal reflux disease in children with episodes of recurrent wheeze
Scientific Title:Acronym gastroesophageal reflux disease in children with episodes of recurrent wheeze
Region
Japan

Condition
Condition wheezing infant
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Association of gastroesophageal reflux disease in children with episodes of recurrent wheeze
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes diagnosis of gastroesophageal reflux disease based on efficacy of famotidine therapy
Key secondary outcomes baseline of pH monitoring

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 pH monitoring is undertaken in all subjects, and all subjects prescribe for famotidine therapy
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
0 years-old <=
Age-upper limit
6 years-old >=
Gender Male and Female
Key inclusion criteria children with episodes of recurrent wheeze evenif they use inhaled corticosteroid
Key exclusion criteria children with pulmonary disease, neurological disease and other basic disorders.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukinori Yoshida
Organization osaka prefectural medical center for respiratory and allergic disease
Division name pediatrics
Zip code
Address 3-7-1 habikino habikino city osaka 583-8588 japan
TEL 072-957-2121
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization osaka prefectural medical center for respiratory and allergic disease
Division name pediatrics
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute osaka prefectural medical center for respiratory and allergic disease
Institute
Department

Funding Source
Organization no funding source
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
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
2011 Year 03 Month 08 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 Enrolling by invitation
Date of protocol fixation
2009 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 01 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
2011 Year 03 Month 06 Day
Last modified on
2011 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006180

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.