UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021217 |
|---|---|
| Receipt number | R000024470 |
| Scientific Title | Do proton pump inhibitors exacerbate NSAIDs-induced small bowel injury?: A prospective, placebo-control, double-blind, randomized trial |
| Date of disclosure of the study information | 2016/02/26 |
| Last modified on | 2016/03/10 16:13:16 |
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Basic information
Public title
Do proton pump inhibitors exacerbate NSAIDs-induced small bowel injury?: A prospective, placebo-control, double-blind, randomized trial
Acronym
Do proton pump inhibitors exacerbate NSAIDs-induced small bowel injury?: A prospective, placebo-control, double-blind, randomized trial
Scientific Title
Do proton pump inhibitors exacerbate NSAIDs-induced small bowel injury?: A prospective, placebo-control, double-blind, randomized trial
Scientific Title:Acronym
Do proton pump inhibitors exacerbate NSAIDs-induced small bowel injury?: A prospective, placebo-control, double-blind, randomized trial
Region
| Japan |
Condition
Condition
NSAIDs-induced small bowel injury
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of bad effect of proton pump inhibitor to NSAIDs-induced small bowel injury
Basic objectives2
Others
Basic objectives -Others
side effect
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of small bowel injury in capsule endoscopy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
NSAIDs(diclofenac 25mg, three times a day) and proton pump inhititor (omeprazole 20mg, twice daily) for 14days
Interventions/Control_2
NSAIDs(diclofenac 25mg, three times a day) and placebo (lactose, twice daily) for 14days
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
healthy volunteers
Key exclusion criteria
1) H. pylori infection
2) history of gastroduodenal ulcer
3) anemia
4) disorder of liver function
5) disorder of kidney function
6) hypertension
7) cardiac failure
8) aspirin-induced asthma
9) hypersensitivity to diclofenac or omeprazole
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mototsugu Kato |
Organization
Hokkaido university hospital
Division name
Division of endoscopy
Zip code
Address
Kita 14 jo Nishi 5 chome, Kitaku, Sapporo, Hokkaido
TEL
011-716-1161
m-kato@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saori Omori |
Organization
Iwamizawa municipal general hospital
Division name
Department of gastroenterology
Zip code
Address
9 jo Nishi 7, Iwamizawa Hokkaido
TEL
0126-22-1650
Homepage URL
m990053@live.jp
Sponsor or person
Institute
Hokkaido university hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido university
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
| 2016 | Year | 02 | Month | 26 | 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
| 2012 | Year | 08 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | 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
| 2016 | Year | 02 | Month | 26 | Day |
Last modified on
| 2016 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024470
