UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003687 |
|---|---|
| Receipt number | R000004466 |
| Scientific Title | Prevention of asprin-induced small-intestinal injury by Poraprezinc |
| Date of disclosure of the study information | 2010/06/01 |
| Last modified on | 2013/03/27 00:56:48 |
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Basic information
Public title
Prevention of asprin-induced small-intestinal injury by Poraprezinc
Acronym
Prevention of asprin-induced small-intestinal injury by Poraprezinc
Scientific Title
Prevention of asprin-induced small-intestinal injury by Poraprezinc
Scientific Title:Acronym
Prevention of asprin-induced small-intestinal injury by Poraprezinc
Region
| Japan |
Condition
Condition
small-intestinal injury
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of Prevention for asprin-induced small-intestinal injury by Poraprezinc
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Incidence of asprin-induced small-intestinal injury (redness, erosion, ulcer)
2. Evaluation of endoscopic findings with capsule endoscopy after taking Poraprezinc or not.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
taking Poraprezinc for 4 weeks
Interventions/Control_2
follow-up without any medication
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. History of taking Asprin
2. With no antibiotic substance
3. Negative for disease germ from feces examination
4. Over 20 years old
5. Agreement of informed concent
Key exclusion criteria
1. Patients with inflammatory bowel disease
2. Patients with digestion and absorption disorder
3. Patients who is taking Poraprezinc
4. Patients who is taking other medicines for gastritis, such as Misoprostol, Rebamipide, etc.
5. Patients who is taking Penicillamine and Levothyroxine sodium
6. Patients with stenosis of gastrointestinal tract and severe adhesion
7. Pregnant and nursing women
8. Patients with severe ulcerative lesion with capsule endoscopy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Tanaka |
Organization
Hiroshima University Hospital
Division name
Department of Endoscopy
Zip code
Address
1-2-3 Kasumi Minamiku Hiroshima, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hiroshima University Hospital
Division name
Department of Endoscopy
Zip code
Address
TEL
082-257-5537
Homepage URL
oka4683@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Endoscopy, Hiroshima 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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | 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
Completed
Date of protocol fixation
| 2009 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 01 | Day |
Last modified on
| 2013 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004466
