UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001937 |
|---|---|
| Receipt number | 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 09:15:17 |
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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
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
Sponsor or person
Institute
Department of Gastroenterology Juntendo University School of Medicine
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002357
