UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014766 |
|---|---|
| Receipt number | R000017158 |
| Scientific Title | A randomized clinical study evaluating the efficacy and tolerance of a new, reduced-volume, bowel preparation for colonoscopy ; a comparison between two different regimens |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2018/02/07 20:27:29 |
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Basic information
Public title
A randomized clinical study evaluating the efficacy and tolerance of a new, reduced-volume, bowel preparation for colonoscopy ; a comparison between two different regimens
Acronym
A randomized clinical study evaluating the efficacy and tolerance of a new, reduced-volume, bowel preparation for colonoscopy ; a comparison between two different regimens
Scientific Title
A randomized clinical study evaluating the efficacy and tolerance of a new, reduced-volume, bowel preparation for colonoscopy ; a comparison between two different regimens
Scientific Title:Acronym
A randomized clinical study evaluating the efficacy and tolerance of a new, reduced-volume, bowel preparation for colonoscopy ; a comparison between two different regimens
Region
| Japan |
Condition
Condition
general population
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and tolerance of a new, reduced-volume, bowel preparation for colonoscopy; a comparison between two different regimens
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of bowel preparation
Key secondary outcomes
tolerance, safty, and mucosal visibility
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Standard regimen:(MOV1000ml+Water500ml+MOV500ml+Water250ml)1time
Interventions/Control_2
Division regimen:(MOV500ml+Water250ml)3times
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
1) Outpatients who are intend to perform colonoscopy
2) Patients who agreed to participate in this research with written informed consent.
Key exclusion criteria
Patients with the following clinical features were excluded: significant cardiac, renal, hepatic, or metabolic co-morbidities, ascites, severe constipation (<2 bowel movement a week), known allergy to PEG-electrolyte solution, history of gastric stapling or bypass procedure, or a history of prior colonic or rectal surgery. Patients were excluded if there was a suspected diagnosis of intestinal obstruction because of advanced colorectal cancer.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Tajika |
Organization
Aichi Cancer Center Hospital
Division name
Department of Endoscopy
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya City, Japan
TEL
052-762-6111
mtajika@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Tajika |
Organization
Aichi Cancer Center Hospital
Division name
Department of Endoscopy
Zip code
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, JAPAN
TEL
052-762-6111
Homepage URL
mtajika@aichi-cc.jp
Sponsor or person
Institute
Department of Endoscopy,Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Pharmaceuticals CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | 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
| 2014 | Year | 08 | Month | 05 | Day |
Last modified on
| 2018 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017158
| 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 |
