UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011505
Receipt No. R000013460
Scientific Title Efficacy and tolerability of low-volume polyethylene glycol solution (Moviprep) versus standard polyethylene glycol solution (Niflec) in bowel preparation for colonoscopy
Date of disclosure of the study information 2013/08/19
Last modified on 2015/11/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy and tolerability of low-volume polyethylene glycol solution (Moviprep) versus standard polyethylene glycol solution (Niflec) in bowel preparation for colonoscopy
Acronym Efficacy and tolerability of low-volume polyethylene glycol solution (Moviprep) versus standard polyethylene glycol solution (Niflec) in bowel preparation for colonoscopy
Scientific Title Efficacy and tolerability of low-volume polyethylene glycol solution (Moviprep) versus standard polyethylene glycol solution (Niflec) in bowel preparation for colonoscopy
Scientific Title:Acronym Efficacy and tolerability of low-volume polyethylene glycol solution (Moviprep) versus standard polyethylene glycol solution (Niflec) in bowel preparation for colonoscopy
Region
Japan

Condition
Condition Bowel preparation for colonoscopy
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Randomized Controlled Trial of Moviprep and Niflec for Bowel Preparation before colonoscopy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patient's Acceptance and Tolerability
Key secondary outcomes Efficacy and Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Bowel preparation for colonoscopy using Niflec
Interventions/Control_2 Bowel preparation for colonoscopy using Moviprep
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) Inpatients who are intend to resect colon polyp
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 100

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, JAPAN
TEL 052-762-6111
Email 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
Email mtajika@aichi-cc.jp

Sponsor
Institute Department of Endoscopy, Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization Department of Endoscopy, Aichi Cancer Center 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
Email

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
2013 Year 08 Month 19 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 06 Month 14 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 21 Day
Last follow-up date
Date of closure to data entry
2014 Year 09 Month 01 Day
Date trial data considered complete
2014 Year 09 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 17 Day
Last modified on
2015 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013460

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.