UMIN-CTR Clinical Trial

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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