UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002621
Receipt number 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 18:23:30

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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 or person

Institute

Kawasaki Medical School attachment Kawasaki hospital Gastroenterology

Institute

Department

Personal name



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

Value
https://center6.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