UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018152 |
|---|---|
| Receipt number | R000020987 |
| Scientific Title | Dose antispasmodic agents administration at the cecum in the colon increase adenoma detection rates by colonoscopy ? : a randomized double-blind placebo-controlled trial |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2016/07/08 18:17:10 |
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Basic information
Public title
Dose antispasmodic agents administration at the cecum in the colon increase adenoma detection rates by colonoscopy ?
: a randomized double-blind placebo-controlled trial
Acronym
The effect of antispasmodic agents for the adenoma detection by colonosocpy
Scientific Title
Dose antispasmodic agents administration at the cecum in the colon increase adenoma detection rates by colonoscopy ?
: a randomized double-blind placebo-controlled trial
Scientific Title:Acronym
The effect of antispasmodic agents for the adenoma detection by colonosocpy
Region
| Japan |
Condition
Condition
Colonic adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of antispasmodic agents administration at the cecum in the colon increase adenoma detection rate by colonoscopy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Adenoma detection rate of the colon
Key secondary outcomes
Side effects of antispasmodic agents
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Antispasmodic agents administration
Interventions/Control_2
Normal saline administration
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Inpatients and outpatients of Sentohiru hospital who have the positive of fecal occult blood test or
clinical symptoms (Ex: hematochesia, abdominal pain, constipation).
2) Inpatients and outpatients of Sentohiru hospital who are scheduled to examine the colon for polyp surveillance.
Key exclusion criteria
1.Patients with ileus.
2.Pregnant and lactating patients.
3.Patients after the colectomy.
4.Patients with colon cancer.
5.Patients with inflammatory bowel disease
6.Patients with FAP or HNPCC
7.Patients who judged inappropriate for clinical trial for severe comorbidity.
8.Patients with DM and Ischemic heart disease or BPH or Glaucoma.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Higaki |
Organization
Sentohiru Hospital
Division name
Depertment of Gastroenterology
Zip code
Address
3-7-18 Imamurakita,Ube,Yamaguchi
TEL
0836-51-5111
shigaki@sthill-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mineko Nagasaki |
Organization
Sentohiru Hospital
Division name
Respiratory division
Zip code
Address
3-7-18 Imamurakita,Ube,Yamaguchi
TEL
0836-51-5111
Homepage URL
nishikiwa@sthill-hp.or.jp
Sponsor or person
Institute
Sentohiru Hospital
Institute
Department
Personal name
Funding Source
Organization
Sentohiru 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
| 2015 | Year | 07 | 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 01 | Day |
Last modified on
| 2016 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020987
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
