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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002621
Receipt No. R000003195
Scientific Title Examination of utility of PPI on-demand treatment to the epigastrium symptom and the best dosage
Date of disclosure of the study information 2009/11/01
Last modified on 2012/02/27

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Basic information
Public title Examination of utility of PPI on-demand treatment to the epigastrium symptom and the best dosage
Acronym Examination of utility of PPI on-demand treatment to the epigastrium symptom and the best dosage
Scientific Title Examination of utility of PPI on-demand treatment to the epigastrium symptom and the best dosage
Scientific Title:Acronym Examination of utility of PPI on-demand treatment to the epigastrium symptom and the best dosage
Region
Japan

Condition
Condition The epigastrium symptom
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It makes comparative study of the utility after four weeks of the on-demand administering of the omeprazole 20mg, the omeprazole 20mg the continuity new administering, and the omeprazole 10mg the continuity new administering for the patient who has the epigastrium symptom.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of change of GOS score between before and after treatment
Key secondary outcomes Examination according to symptoms
Evaluation of safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 "on demand" therapy of omepral 20mg for 4 weeks
Interventions/Control_2 continuous therapy of omepral 20mg for 4 weeks
Interventions/Control_3 continuous therapy of omepral 10mg for 4 weeks
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 1)The patient of the endoscopy unexecution within three months in the past. there are a repetition of the relapse ..chronic.. and an abdomen symptom
2)It is a symptom questionnaire survey and the GOS score is a patient of four or more.
3)H. pylori is a gloomy patient in urine according to the antibody method.
Key exclusion criteria 1) Pregnant women and patienst while suckling, and patients who have been hoping for pregnancy for the trial period.
2) Patients who had the past of irritability for omeprazole

3) Patients who suffer from serious liver disease, kidney disease, heart disease, or Haematological disorder

4) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size 240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name oshinori Fujimura
Organization Kawasaki Medical School attachment Kawasaki hospital
Division name Gastroenterology
Zip code
Address Okayama Prefecture Okayama City Kita Ward nakayange 2-1-80
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Fujimura
Organization Kawasaki Medical School Kawasaki hospital
Division name Gastroenterology
Zip code
Address
TEL 066-462-1111
Homepage URL
Email

Sponsor
Institute Kawasaki Medical School attachment Kawasaki hospital Gastroenterology
Institute
Department

Funding Source
Organization none
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
2009 Year 11 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 Completed
Date of protocol fixation
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 Year 02 Month 01 Day
Date of closure to data entry
2011 Year 10 Month 01 Day
Date trial data considered complete
2012 Year 02 Month 01 Day
Date analysis concluded
2012 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 12 Day
Last modified on
2012 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003195

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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