UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005094
Receipt number 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 17:20:58

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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 or person

Institute

Kamigoto Hospital

Institute

Department

Personal name



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

Value
https://center6.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