UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008101 |
|---|---|
| Receipt number | R000009534 |
| Scientific Title | Antispastic efficasy of l-menthol spray on the duodenal mucosa compared with intravenous administration of scopolamine butylbromide for endoscopic retrograde cholangiopancreatography (ERCP) |
| Date of disclosure of the study information | 2012/06/04 |
| Last modified on | 2012/06/04 19:11:36 |
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Basic information
Public title
Antispastic efficasy of l-menthol spray on the duodenal mucosa compared with intravenous administration of scopolamine butylbromide for endoscopic retrograde cholangiopancreatography (ERCP)
Acronym
Antispastic efficasy of l-menthol compared with scopolamine butylbromide for ERCP
Scientific Title
Antispastic efficasy of l-menthol spray on the duodenal mucosa compared with intravenous administration of scopolamine butylbromide for endoscopic retrograde cholangiopancreatography (ERCP)
Scientific Title:Acronym
Antispastic efficasy of l-menthol compared with scopolamine butylbromide for ERCP
Region
| Japan |
Condition
Condition
biliary tract disease
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the duodenal antiperistaltic effect of 1.6% l-menthol spray on the duodenal mucosa compared with that of scopolamine butylbromide intravenous administration during endoscopic retrograde cholangiopancreatography.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was the rate of peristalsis suppression of duodenum after treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
l-mentol spray on the duodenal mucosa during ERCP
Interventions/Control_2
scopolamine butylbromide intravenous administration during ERCP
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 study group included patients who required cholangiography.
Patients who are planned ERCP. Patients or their family who fully understand and are willing to give a written informed consent about participation.
Key exclusion criteria
age 20 years younger; severe heart disease; severe lung disease; prostatic hyperplasia; glaucoma; contraindication to scopolamine butylbromide; pregnant and breast-feeding women or women suspected of being pregnant; women are not willing to avoid pregnancy during the duration of study; acute pancreatitis; chronic pancreatitis with an acute exacerbation; post gastrectomy; biliary cannulation using with Rendezvous method; contrast medium allergy; or refusal to provide informed consent.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Tokita |
Organization
Kyoto prefectural Yosanoumi hospital
Division name
Department of gastroenterology and hepatology
Zip code
Address
481 Otokoyama Yosano-cho, 629-2261 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Gen |
Organization
Kyoto prefectural Yosanoumi hospital
Division name
Department of gastroenterology and hepatology
Zip code
Address
TEL
Homepage URL
y-gen6-4@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto prefectural Yosanoumi hospital
Institute
Department
Personal name
Funding Source
Organization
Kyoto prefectural Yosanoumi hospital
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
| 2012 | Year | 06 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | 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
| 2012 | Year | 06 | Month | 04 | Day |
Last modified on
| 2012 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009534
