UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023383 |
|---|---|
| Receipt number | R000026946 |
| Scientific Title | L-menthol and carbon dioxide improve adenoma detection rate during colonoscopy; a randomized trial |
| Date of disclosure of the study information | 2016/07/28 |
| Last modified on | 2018/01/08 16:50:36 |
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Basic information
Public title
L-menthol and carbon dioxide improve adenoma detection rate during colonoscopy; a randomized trial
Acronym
L-menthol and carbon dioxide improve adenoma detection rate during colonoscopy; a randomized trial
Scientific Title
L-menthol and carbon dioxide improve adenoma detection rate during colonoscopy; a randomized trial
Scientific Title:Acronym
L-menthol and carbon dioxide improve adenoma detection rate during colonoscopy; a randomized trial
Region
| Japan |
Condition
Condition
Colorectal neoplasmas
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy and safety of L-menthol spray as an antiperistaltic agent with carbon dioxide insufflation and their effects on adenoma detection rate during colonoscopy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The colorectal adenoma detection rate between the L-menthol with carbon dioxide group and the placebo group.
Key secondary outcomes
The proportion of patients with no peristalsis, the withdrawal time and the pain during colonoscopy between the L-menthol with carbon dioxide group and the placebo group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
0.8% l-Menthol with Carbon dioxide
Interventions/Control_2
0.8% l-Menthol with Air
Interventions/Control_3
Water with dimeticon with Carbon dioxide
Interventions/Control_4
Water with dimeticon with Air
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 undergoing colonoscopy for the investigation of positive results of a fecal occult blood test screening, screening colonoscopy or surveillance colonoscopy after postendoscopic resection of colorectal neoplasmas.
Key exclusion criteria
Patients were excluded if they had any of the following: a history of colectomy,symptoms suggesting possible colorectal stenosis or cancer, inflammatory bowel disease, familial polyposis, or known CRC, severe organ failure, noncorrectable coagulopathy, or antithrombotic therapy.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Okuda |
Organization
Fukuchiyama City Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
231 Atsunaka-cho, Fukuchiyama-city, Kyoto, 620-0056, Japan
TEL
+81-773-22-2101
okudatti@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Inoue |
Organization
Fukuchiyama City Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
231 Atsunaka-cho, Fukuchiyama-city, Kyoto, 620-0056, Japan
TEL
+81-773-22-2101
Homepage URL
keninoue71@koto.kpu-m.ac.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology,Fukuchiyama City Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology and Hepatology,Fukuchiyama City 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
| 2016 | Year | 07 | Month | 28 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | 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
| 2016 | Year | 07 | Month | 28 | Day |
Last modified on
| 2018 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026946
