UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000679 |
|---|---|
| Receipt number | R000000812 |
| Scientific Title | A study for the effect of ulinastatin for suppression of hyperamylasemia and hyperlipasemia induced by peroral double-balloon enteroscopy |
| Date of disclosure of the study information | 2007/10/01 |
| Last modified on | 2011/10/13 17:09:01 |
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Basic information
Public title
A study for the effect of ulinastatin for suppression of hyperamylasemia and hyperlipasemia induced by peroral double-balloon enteroscopy
Acronym
DBE-ulinastatin study
Scientific Title
A study for the effect of ulinastatin for suppression of hyperamylasemia and hyperlipasemia induced by peroral double-balloon enteroscopy
Scientific Title:Acronym
DBE-ulinastatin study
Region
| Japan |
Condition
Condition
Patients who undergo peroral double-balloon enteroscopy
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clalify whether ulinastatin has a suppressive effect for hyperamylasemia and hyperlipasemia induced by peroral double-balloon enteroscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
serum pancreatic amylase level and serum lipase level 3 hours after and in the next morning of peroral double-balloon enteroscopy
Key secondary outcomes
presence or absence of pancreatitis after peroral double-balloon enteroscopy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
An intravenous drip injection of 150,000 U of ulinastatin dissolved in 100 ml of physiological saline for 2 hours from the start of peroral double-balloon enteroscopy
Interventions/Control_2
An intravenous drip injection of 100 ml of physiological saline for 2 hours from the start of peroral double-balloon enteroscopy
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
Patients who undergo peroral double-balloon enteroscopy who are 20 years of age or older, are able to understand the concerned clinical study and give written informed consent.
Key exclusion criteria
(1) patients who have acute pancreatitis or chronic pancreatitis
(2) patients with known hypersensitivity to ulinastatin
(3) women who are pregnant or possible pregnant
(4) patients taking endoscopy which is not aiming the insertion of endoscope deep into the small intestine
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nakamura |
Organization
Kyushu University
Division name
Department of Medicine and Bioregulatory Science
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-city, Fukuoka-prefecture
TEL
092-642-5286
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nakamura |
Organization
Kyushu University
Division name
Department of Medicine and Bioregulatory Science
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-city, Fukuoka-prefecture
TEL
092-642-5286
Homepage URL
knakamur@intmed3.med.kyushu-u.ac.jp
Sponsor or person
Institute
Intmed3 DBE study group
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
| 2007 | Year | 10 | 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
| 2007 | Year | 01 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 04 | Month | 16 | Day |
Last modified on
| 2011 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000812
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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