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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005094
Receipt No. R000006029
Scientific Title A controlled study of efficacy and safety in CT colonography preparation with Mosapride Citrate Hydrate
Date of disclosure of the study information 2011/02/16
Last modified on 2014/02/19

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Basic information
Public title A controlled study of efficacy and safety in CT colonography preparation with Mosapride Citrate Hydrate
Acronym A controlled study of efficacy and safety in CT colonography preparation with Mosapride Citrate Hydrate
Scientific Title A controlled study of efficacy and safety in CT colonography preparation with Mosapride Citrate Hydrate
Scientific Title:Acronym A controlled study of efficacy and safety in CT colonography preparation with Mosapride Citrate Hydrate
Region
Japan

Condition
Condition colorectal cancer, colorectal polyp
Classification by specialty
Gastroenterology Radiology Laboratory medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy, tolerability, and safety of a new polyethylene glycol lavage solution plus contrast medium and Mosapride Citrate Hydrate (PEG-CM) with a PEG-C (without Mosapride Citrate Hydrate ) as bowel preparation before CT colonography.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes PEG-C versus PEG-C + Mosapride Citrate Hydrate for bowel preparation before CT colonography to be asscessed by the amount of residual fluid.
Key secondary outcomes Comparative adherence of patients to PEG-C preparation and PEG-C + Mosapride Citrate Hydrate preparation.
Frequency and nature of any adverse events.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Polyethylene glycol lavage solution plus contrast medium (PEG-C) preparation before CT colonography
Interventions/Control_2 Polyethylene glycol lavage solution plus contrast medium and Mosapride Citrate Hydrate (PEG-CM) preparation before CT colonography
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) Patients who are eligible for optical colonoscopy.
2) Aged 20 years or older.
3) Major functions of organs of the subjects are in a good condition.
4) Signed informed consent forms are obtained by the patients.
Key exclusion criteria 1) Serious medical conditions that may increase the risk of optical colonoscopy or are so severe that screening would have no benefit.
2) Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
3) Evidence of an increased risk in carrying out bowel preparation or CTC exams.
4) Possibility of pregnancy.
5) Patients with psychological conditions that contraindicate colonoscopy or make them irrelevant to participate in the trial.
6) Iodine hypersensitivity.
7) Severe thyroid disease.
8) Claustrophobia.
9) Severe deafness.
10) Subjects whose eligibility for this clinical trial is not appropriate by other reasons.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuro Honda, Takahiro Yasaka
Organization Kamigoto Hospital
Division name Department of Internal Medicine, Department of Surgery
Zip code
Address 1549-11, Aokatago, Shin-Kamigoto, Minami-matsuura, Nagasaki, Japan, 857-4404
TEL 0959-52-3000
Email tetsupeacevo@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuro Honda
Organization Kamigoto Hospital
Division name Kamigoto Hospital
Zip code
Address 1549-11, Aokatago, Shin-Kamigoto, Minami-matsuura, Nagasaki, Japan, 857-4404
TEL 0959-52-3000
Homepage URL
Email tetsupeacevo@yahoo.co.jp

Sponsor
Institute Kamigoto 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 上五島病院(長崎県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 16 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 Open public recruiting
Date of protocol fixation
2009 Year 08 Month 02 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2013 Year 09 Month 01 Day
Date trial data considered complete
2013 Year 10 Month 30 Day
Date analysis concluded
2013 Year 12 Month 15 Day

Other
Other related information

Management information
Registered date
2011 Year 02 Month 16 Day
Last modified on
2014 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006029

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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