Unique ID issued by UMIN | UMIN000008008 |
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Receipt number | R000009403 |
Scientific Title | Efficacy of L-menthol(MINCLEA®) as an antispasmodic during endoscopic retrograde cholangiopancreatography(ERCP) |
Date of disclosure of the study information | 2012/05/22 |
Last modified on | 2013/12/22 15:54:34 |
Efficacy of L-menthol(MINCLEA®) as an antispasmodic during endoscopic retrograde cholangiopancreatography(ERCP)
Efficacy of L-menthol during endoscopic retrograde cholangiopancreatography(ERCP)
Efficacy of L-menthol(MINCLEA®) as an antispasmodic during endoscopic retrograde cholangiopancreatography(ERCP)
Efficacy of L-menthol during endoscopic retrograde cholangiopancreatography(ERCP)
Japan |
biliary and pancreatic disease
Gastroenterology | Hepato-biliary-pancreatic medicine |
Others
NO
We assess the efficacy and safety of L-menthol(MINCLEA®) as an antispasmodic during ERCP compared with glucagon. Furthermore, we evaluate the effect to sphincter muscle of papilla Vater.
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
the proportion of subjects with antiperistaltic effect
1. the proportion of subjects who finished the procedure without additional antispasmodic agents
2. complications
3. the interval from administration of antispasmodic agents to success of cannulation (except the subjects of post-sphincterotomy)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Medicine |
Continuous 50 patients undergo ERCP with 1mg of glucagon(Glucagon G Novo, JAN code:4987028509318) injected intravenously.
Continuous 50 patients undergo ERCP with 20ml of 0.8% L-menthol(MINCLEA,JAN code:4987123152969)(160mg) sprayed on the duodenum.
Not applicable |
Not applicable |
Male and Female
the patients with indication of ERCP
1. the emergency patients
2. the patients with bad general conditions
3. the patients judged inappropriate by their doctors
4. contraindication of glucagon or L-menthol
100
1st name | |
Middle name | |
Last name | Kenjiro Yasuda |
Kyoto Second Red Cross Hospital
Gastroenterology
355-5 Haruobi-cho Kamigyo-ku Kyoto 602-8026, Japan
075-231-5171
1st name | |
Middle name | |
Last name | Hideaki Kawabata |
Kyoto Second Red Cross Hospital
Gastroenterology
355-5 Haruobi-cho Kamigyo-ku Kyoto 602-8026, Japan
075-231-5171
kawabatah@kyoto2.jrc.or.jp
Kyoto Second Red Cross Hospital
Kyoto Second Red Cross Hospital
Self funding
NO
京都第二赤十字病院
2012 | Year | 05 | Month | 22 | Day |
Unpublished
Enrolling by invitation
2012 | Year | 01 | Month | 24 | Day |
2012 | Year | 04 | Month | 01 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 12 | Month | 31 | Day |
2015 | Year | 01 | Month | 31 | Day |
2012 | Year | 05 | Month | 21 | Day |
2013 | Year | 12 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009403
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