UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001696 |
|---|---|
| Receipt number | R000002039 |
| Scientific Title | A small amount of polyethylene glycol solution as a preparation for capsule endoscopy |
| Date of disclosure of the study information | 2009/02/09 |
| Last modified on | 2010/12/24 19:52:26 |
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Basic information
Public title
A small amount of polyethylene glycol solution as a preparation for capsule endoscopy
Acronym
Small amount of PEG for capsule endoscopy
Scientific Title
A small amount of polyethylene glycol solution as a preparation for capsule endoscopy
Scientific Title:Acronym
Small amount of PEG for capsule endoscopy
Region
| Japan |
Condition
Condition
small intestinal disorders
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of a small amount of polyethylene glycol solution as a preparation for capsule endoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
image quality of capsule endoscopy
Key secondary outcomes
completion rate to the cecum
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
To ingest 500ml of polyethylene glycol solution within a 2-h period starting 30 minutes after swallowing the capsule
Interventions/Control_2
To ingest no polyethylene glycol solution
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
subjects with gastrointestinal bleeding who have no hemorrhage-causing lesions on gastroscopy and total colonoscopy
Key exclusion criteria
subjects with a history of small bowel resection.
subjects with or suspected for intestinal stenosis.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Matsuhashi |
Organization
Kanto Medical Center, NTT East
Division name
Department of Gastroenterology
Zip code
Address
5-9-22 Higashi-gotanda, Shinagawa-ku, Tokyo
TEL
03-3448-6245
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kanto Medical Center, NTT East
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
nmatuha-tky@umin.ac.jp
Sponsor or person
Institute
Kanto Medical Center, NTT East
Institute
Department
Personal name
Funding Source
Organization
Kanto Medical Center, NTT East
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 02 | Month | 09 | 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
| 2009 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 09 | Day |
Last modified on
| 2010 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002039
