UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008736 |
|---|---|
| Receipt number | R000010108 |
| Scientific Title | Efficacy of Esmeprazole and Lansoprazole in patients with upper gastrointestinal symptpms taking non-steroida anti-inflammatory drugs |
| Date of disclosure of the study information | 2012/08/20 |
| Last modified on | 2012/08/20 20:00:02 |
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Basic information
Public title
Efficacy of Esmeprazole and Lansoprazole in patients with upper gastrointestinal symptpms taking non-steroida anti-inflammatory drugs
Acronym
Efficacy of Esmeprazole and Lansoprazole
Scientific Title
Efficacy of Esmeprazole and Lansoprazole in patients with upper gastrointestinal symptpms taking non-steroida anti-inflammatory drugs
Scientific Title:Acronym
Efficacy of Esmeprazole and Lansoprazole
Region
| Japan |
Condition
Condition
(1)continuous in use about NSAIDs aged 20 and over.
(2) The patient who has an anamnesis of digestive ulcer.
(3) The patient at least whose one item it is at the research registration time and is three or more points in the question item of a GOS interview sheet.
(4) Those by whom the consent of research participation was got with the document.
Classification by specialty
| Gastroenterology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is examined how the GOS abdominal-symptoms synthesis score at the time of start of the research changes in an example while using NSAIDs by medication of 20 mg of Esomeprasolof two weeks after, or 15 mg of run Soprasole.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Global Overall Symptom scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A group (Esomeprazole medication)
Esomeprazole 20mg once before breakfast for 2weeks
Interventions/Control_2
B group (Lansoprazole medication) groups.
Lansoprazole 15mg once before breakfast for two 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) He is man and woman continuous in use about NSAIDs aged 20 and over.
(2) The patient who has an anamnesis of digestive ulcer.
(3) The patient at least whose one item it is at the research registration time and is three or more points in the question item of a GOS interview sheet.
(4) Those by whom the consent of research participation was got with the document.
Key exclusion criteria
Except the above
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Uchio |
Organization
Shimane University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
89-1Enyacho Izumo City
TEL
0853-20-2242
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Uchio |
Organization
Shimane University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
TEL
Homepage URL
uchio@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery Shimane University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Orthopaedic Surgery Shimane University School of Medicine
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
島根大学医学部附属病院、出雲市立総合医療センター 松江赤十字病院 隠岐病院 かじたに整形外科医院 かつべ整形外科医院 えだクリニック 平成記念病院 出雲市民病院 浜田医療センター(島根県） 若草第一病院(大阪府）IHI播磨病院(兵庫県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 20 | 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
| 2012 | Year | 08 | Month | 20 | Day |
Last modified on
| 2012 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010108
