UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003788 |
|---|---|
| Receipt number | 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 17:09:44 |
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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
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
jiijima@int3.med.tohoku.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Tohoku University Hospital
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
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
Value
https://center6.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 | |
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| Registered date | File name |
