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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003788
Receipt No. R000004582
Scientific Title Effect of etdolac on gastric acid and mucous secretion –comparison with naproxen-
Date of disclosure of the study information 2010/08/01
Last modified on 2012/06/22

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Basic information
Public title Effect of etdolac on gastric acid and mucous secretion –comparison with naproxen-
Acronym Effect of etdolac on gastric acid and mucous secretion
Scientific Title Effect of etdolac on gastric acid and mucous secretion –comparison with naproxen-
Scientific Title:Acronym Effect of etdolac on gastric acid and mucous secretion
Region
Japan

Condition
Condition Healthy male volunteers
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect on gastric physiological function between a COX-2 highly selective NSAID, etdolac and an ordinary naproxen NSAID.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Endoscopic gastric mucosal injury
Gastric acid secretion
Gastric mucous secretion
Key secondary outcomes Subjective Symptom Score

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 etdolac
Interventions/Control_2 naproxen
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 H. pylori-negative healthy volunteers
Key exclusion criteria H. pylori-positive subjects
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Iijima Katsunori
Organization Tohoku University Hospital
Division name Division of Gastroenterology
Zip code
Address 1-1, Seiryo-machi, Aobaku, Sendai 980-8574, Japan.
TEL 022-717-7171
Email

Public contact
Name of contact person
1st name
Middle name
Last name Iijima Katsunori
Organization Tohoku University Hospital
Division name Division of Gastroenterology
Zip code
Address 1-1, Seiryo-machi, Aobaku, Sendai 980-8574, Japan.
TEL 022-717-7171
Homepage URL
Email jiijima@int3.med.tohoku.ac.jp

Sponsor
Institute Division of Gastroenterology, Tohoku University Hospital
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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 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 No longer recruiting
Date of protocol fixation
2009 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 06 Month 19 Day
Last modified on
2012 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004582

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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