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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001937
Receipt No. R000002357
Scientific Title Randomized parallel controlled trial of "on demand" therapy versus continuous therapy of omepral 20mg in effectiveness and safety for the patients {Los Angeles classification grade M (LA M) or more)} diagnosed as the gastroesophageal reflux disease.
Date of disclosure of the study information 2009/05/02
Last modified on 2013/07/08

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Basic information
Public title Randomized parallel controlled trial of "on demand" therapy versus continuous therapy of omepral 20mg in effectiveness and safety for the patients {Los Angeles classification grade M (LA M) or more)} diagnosed as the gastroesophageal reflux disease.
Acronym Randomized parallel controlled trial of refiux esophagitis
Scientific Title Randomized parallel controlled trial of "on demand" therapy versus continuous therapy of omepral 20mg in effectiveness and safety for the patients {Los Angeles classification grade M (LA M) or more)} diagnosed as the gastroesophageal reflux disease.
Scientific Title:Acronym Randomized parallel controlled trial of refiux esophagitis
Region
Japan

Condition
Condition Gastroesophageal reflux disease (LA gradeM or more)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Endoscopy examination is done after 8-weeks of the initial treatment for reflux esophagitis. Patients whose endoscopic diagnosis was LA M or more are included as tested subjects. The aim of the study is to examine whether "on demand" therapy that means to take the medicine only when symptoms occur or continuous therapy of omepral 20mg for 24 weeks for tested subjects is more effective or safer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Amount of change of GOS score between before and after treatment
Amount of change of QULRAS-J 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 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 "on demand" therapy of omepral 20mg for 24 weeks
Interventions/Control_2 continuous therapy of omepral 20mg for 24 weeks
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 1) Patients had been classified into grade LA M, A, B, C, and D by endoscopy before initial treatment and whose endoscopic diagnosis was LA M and more after 8-weeks initial treatment.
2) Patients from who written informed consent was obtained.
Key exclusion criteria 1) Patients who suffer from cancer.
2) Patients who suffer from serious liver disease, kidney disease, heart disease, or Haematological disorder
3) Patients who had the past of irritability for omeprazole
4) Pregnant women and patienst while suckling, and patients who have been hoping for pregnancy for the trial period.
5) Patients who participated in other clinical trials which are thought to influence to the result of this trial within one month before the start of the trial.
6) Patients who refuse endoscopic examination.
7) Patients who suffer from gastric ulcers and/or duodenal ulcers
8) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihito Nagahara
Organization Juntendo University School of Medicine
Division name Gastroenterology
Zip code
Address 2-1-1 Hongo bunkyo-ku tokyo Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akihito Nagahara
Organization Juntendo University School of Medicine
Division name Gastroenterology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Gastroenterology Juntendo University School of Medicine
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 05 Month 02 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 04 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2012 Year 12 Month 31 Day
Date of closure to data entry
2012 Year 12 Month 31 Day
Date trial data considered complete
2013 Year 05 Month 31 Day
Date analysis concluded
2013 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2009 Year 05 Month 02 Day
Last modified on
2013 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002357

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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