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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001556
Receipt No. R000001873
Scientific Title The effect of mosapride citrate on the quality and tolerance of colonic lavage: a double-blind randomized study
Date of disclosure of the study information 2008/12/10
Last modified on 2010/07/22

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Basic information
Public title The effect of mosapride citrate on the quality and tolerance of colonic lavage: a double-blind randomized study
Acronym The effect of mosapride citrate on the quality and tolerance of colonic lavage: a double-blind randomized study
Scientific Title The effect of mosapride citrate on the quality and tolerance of colonic lavage: a double-blind randomized study
Scientific Title:Acronym The effect of mosapride citrate on the quality and tolerance of colonic lavage: a double-blind randomized study
Region
Japan

Condition
Condition colorectal disease
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigate the use of mosapride citrate for improving the efficacy and tolerability of bowel preparation with polyethylene glycol electrolyte lavage.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes tolerability of bowel preparation with polyethylene glycol electrolyte lavage
Key secondary outcomes quality of bowel preparation, consumption time to take lavage, time to first defecation, time to completion of bowel cleansing, additional volume of lavage to completion of bowel cleansing, occurrence of unpleasant abdominal symptom, and posibility of reduction in requred volume of volume of lavage

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Niflec 2000ml with Gasmotin 15mg
Interventions/Control_2 Niflec 2000ml with placebo
Interventions/Control_3 Niflec 1500ml with Gasmotin 15mg
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Out patients who underwent colonoscopy in our hospital
2.patients provided a written informed consent
Key exclusion criteria 1.patients with chronic and acute renal failure (Cr>1.5mg/dl)
2.patients with uncontroled congenital heart failure and unstable angina
3.patients with acute myocardial infarction (AMI) and recieved A-C bypass or intervention for AMI within 3 months
4.abnormal serum sodium, pottassium, phosphorus, and calcium
5.active phase patients with inflammatory bowel disease
6.history of colonic surgery
7.sign of bowel obstruction
8.sign of bowel perforation
9.patients with toxic megacolon
10.patients with suffering from diverticulotitis
11.severe constipatien
12.history of drug allergy
13.sign of pregnancy
14.patients with 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, 464-8681, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Aichi Cancer Center Hospital
Division name Department of Endoscopy
Zip code
Address
TEL 052-762-6111
Homepage URL
Email

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization None
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
2008 Year 12 Month 10 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
2008 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 12 Month 07 Day
Last modified on
2010 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001873

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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