UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001538 |
|---|---|
| Receipt number | R000001728 |
| Scientific Title | Prospective, randomized, double-blind, controlled trial of the healing effect of Polaprezinc for NSAIDs induced small bowel injury. |
| Date of disclosure of the study information | 2008/12/01 |
| Last modified on | 2012/12/01 13:49:22 |
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Basic information
Public title
Prospective, randomized, double-blind, controlled trial of the healing effect of Polaprezinc for NSAIDs induced small bowel injury.
Acronym
Prospective, randomized, double-blind, controlled trial of the healing effect of Polaprezinc for NSAIDs induced small bowel injury.
Scientific Title
Prospective, randomized, double-blind, controlled trial of the healing effect of Polaprezinc for NSAIDs induced small bowel injury.
Scientific Title:Acronym
Prospective, randomized, double-blind, controlled trial of the healing effect of Polaprezinc for NSAIDs induced small bowel injury.
Region
| Japan |
Condition
Condition
NSAIDs-induced small bowel injury
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the healing effect of Polaprezinc for NSAIDs-induced small bowel injury by using video capsule endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Capsule endoscopic findings (number of ulcers/erosions and red spots)
Key secondary outcomes
Laboratory data and subjective symptom
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Polaprezinc
Interventions/Control_2
placebo
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
The patients who have taken NSAIDs for more than one month and who will take NSAIDs for one month after enrollment.
Key exclusion criteria
1) The patients with dysphagia.
2) Pregnant or lactating women.
3) The patients who have history of the ileus or stricture or fistula of the intestine.
4) The patients who have Crohn's disease, Behchet's disease.
5) The patient with pacemaker or other medical electronic equipment.
6) The patient who have taken mucoprotective agent or took it within one month before enrollment.
7) The patient who have severe anemia (less than Hb 8.0mg/dl) or a hematemesis or a melena.
8) The patients who have taken antibiotics or took it within one month before enrollment.
9) The patients who have severe hiatal hernia.
10) The patient who take COX-2 inhibitor (celecoxib) only or low-dose aspirin only.
11) The patients who have severe illness.
12) The patients who have history of abdominal operation or radiation therapy.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Hosoe, M.D., Ph.D. |
Organization
Keio University
Division name
Division of Gastroenterology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Hosoe, M.D., Ph.D. |
Organization
Keio University
Division name
Division of Gastroenterology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
hosenao@db3.so-net.ne.jp
Sponsor or person
Institute
Division of Gastroenterology,Department of Internal Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology,Department of Internal Medicine, Keio University and OLYMPUS medical systems corp. and ZERIA pharmaceutical CO.,Ltd.
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
| 2008 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2011 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 01 | Day |
Last modified on
| 2012 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001728
