UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004710 |
|---|---|
| Receipt number | R000005605 |
| Scientific Title | The evaluation of usefulness of peppermint oil solution as an antispasmodic drug for esophagogastroduodenoscopy. |
| Date of disclosure of the study information | 2010/12/12 |
| Last modified on | 2010/12/12 21:31:51 |
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Basic information
Public title
The evaluation of usefulness of peppermint oil solution as an antispasmodic drug for esophagogastroduodenoscopy.
Acronym
The evaluation of usefulness of peppermint oil solution as an antispasmodic drug for esophagogastroduodenoscopy.
Scientific Title
The evaluation of usefulness of peppermint oil solution as an antispasmodic drug for esophagogastroduodenoscopy.
Scientific Title:Acronym
The evaluation of usefulness of peppermint oil solution as an antispasmodic drug for esophagogastroduodenoscopy.
Region
| Japan |
Condition
Condition
esophagogastric disorder
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and the usefulness of peppermint oil as an antispasmodic during upper endoscopy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of antispasmodic scores was evaluated between the non-elderly patients and elderly patients
Key secondary outcomes
safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A total of 8269 EGD procedures were carried out in Mitoyo General Hospital, Kagawa prefecture and Tsuyama Central Hospital, Okayama prefecture in Japan from March 2007 to September 2010. Peppermint oil was administered intraluminally during the procedure to 1893 patients (Group PO) with heart disease, prostate hypertrophy, and narrow angle glaucoma.
Peppermint oil solution is composed of peppermint oil (Yoshida Pharmaceutical Co.,Tokyo, Japan) distilled water by using the catalyst that is sorbitan monostearate (Wako Pure Chemical Industries, Osaka, Japan). About 20ml of 1.6% peppermint oil solution is administered directly to the antrum of the stomach at an initial stage of the procedure.
Interventions/Control_2
Hyoscine butylbromide (HB) (Buscopan®; Nippon Boehringer Ingelheim, Hyogo, Japan) was administered to the 6063 patients (Group HB)
Interventions/Control_3
Glucagon (GL) (Glucagon G Novo®; Novo Nordisk Pharma Ltd., Tokyo, Japan ) was administered to the 157 patients (Group GL)
Interventions/Control_4
156 patients (Group NO) carried out procedure without antispasmodic agents
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 13 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who are carried out EGD procedure
Key exclusion criteria
Exclusion criteria were clinical evidence of severe diseases such as American Society of Anesthesiologists (ASA) classification of 4 or 5 at the time of procedure, peppermint allergy, and pregnancy or lactation.
Target sample size
8000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Imagawa |
Organization
Mitoyo General Hospital
Division name
Department of Gastroenterology
Zip code
Address
708 Himehama Toyohama, Kan-onji-city, Kagawa, Japan
TEL
0875-52-3366
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Imagawa |
Organization
Mitoyo General Hospital
Division name
Department of Gastroenterology
Zip code
Address
708 Himehama Toyohama, Kan-onji-city, Kagawa, Japan
TEL
Homepage URL
Sponsor or person
Institute
Endoscopy center in Mitoyo General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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 | 12 | Month | 12 | 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
Peppermint oil is efficacious and useful as an antispasmodic during EGD, especially in elderly patients.
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
| 2007 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 12 | Day |
Last modified on
| 2010 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005605
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