UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013103 |
|---|---|
| Receipt number | R000015288 |
| Scientific Title | The safety and efficacy of a new bowel preparation for colonoscopy |
| Date of disclosure of the study information | 2014/02/07 |
| Last modified on | 2016/08/04 17:06:27 |
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Basic information
Public title
The safety and efficacy of a new bowel preparation for colonoscopy
Acronym
The safety and efficacy of a new bowel preparation for colonoscopy
Scientific Title
The safety and efficacy of a new bowel preparation for colonoscopy
Scientific Title:Acronym
The safety and efficacy of a new bowel preparation for colonoscopy
Region
| Japan |
Condition
Condition
candidate for colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the saftey of Niflec, moviprep(Mov) and fractionated MOV for Bowel Preparation before colonoscopy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
Efficacy and Patient's Acceptance and Tolerability
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Bowel preparation using Niflec for colonoscopy
Interventions/Control_2
Bowel preparation using Moviprep for colonoscopy
Interventions/Control_3
Bowel preparation using fractionated Moviprep for colonoscopy
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
Person in need of colonoscopy
Key exclusion criteria
1)Patients with acute or chronic kidney failure (Cre>1.5mg/dL)
2)Patients with heart failure (NYHA class III or IV)
3)Patients performed bypass surgery or with endovascular treatment or myocardial infarction within 3 month's
4)Patients with hyponatremia, hypokalemia or hyperphosphatemia
5)Patients with chronic IBD during an acute exacerbation
6)Patients with a history of gastrointestinal tractresection (excluding appendicectomy)
7)Patients who may have ileus or failure of gastric empty
8)Patients who has perforation and may have perforation of gastrointestinal tract
9)Patients with toxic megacolon
10)In colonoscopy, patients who have a history of colonic diverticula or colonic narrowing with clinical symptoms
11)Patients with severe constipation(<3 times a week of bowel movement for more than a year)
12)Patients with a history of severe drug allergy
13)Women who are pregnant, breast-feeding or likely to be pregnant
14)Patients with advanced colorectal cancer
15)Person who is difficult to get propriety judgment of participation
16)Patients who are considered to be unsuitable by the trial investigators
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIro-o Yamano |
Organization
Akita Red Cross Hospital
Division name
Division of Gastroenterology
Zip code
Address
222-1 Nawashirosawa, Saruta Kamikitade, Akita, JAPAN
TEL
018-829-5000
h-yamano@h9.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIro-o Yamano |
Organization
Akita Red Cross Hospital
Division name
Division of Gastroenterology
Zip code
Address
222-1 Nawashirosawa, Saruta Kamikitade, Akita, JAPAN
TEL
018-829-5000
Homepage URL
h-yamano@h9.dion.ne.jp
Sponsor or person
Institute
Akita Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Pharmaceuticals Co. Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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 | 02 | Month | 07 | 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
| 2013 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 24 | 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 | 02 | Month | 07 | Day |
Last modified on
| 2016 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015288
