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
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
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
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
