UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033105 |
|---|---|
| Receipt number | R000037649 |
| Scientific Title | Intestinal lavage fluid picoprep(R)formulation Internal use group only Picosulfate sodium internal solution 0.75% in combination with the oral administration group Validation on intestinal washing degree |
| Date of disclosure of the study information | 2018/06/26 |
| Last modified on | 2020/02/12 08:13:32 |
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Basic information
Public title
Intestinal lavage fluid picoprep(R)formulation Internal use group only Picosulfate sodium internal solution 0.75% in combination with the oral administration group Validation on intestinal washing degree
Acronym
Comparison between picoprep (R) alone oral administration group and oral administration strengthening group
Scientific Title
Intestinal lavage fluid picoprep(R)formulation Internal use group only Picosulfate sodium internal solution 0.75% in combination with the oral administration group Validation on intestinal washing degree
Scientific Title:Acronym
Comparison between picoprep (R) alone oral administration group and oral administration strengthening group
Region
| Japan |
Condition
Condition
Compare single oral administration group of picoprep (R) and oral administration strengthening group
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study on degree of intestinal cleansing in picoprep (R) alone oral administration group and internal medicine strengthening group
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal washing degree(using Ottawa scale)
Key secondary outcomes
Pretreatment time, presence or absence of addition of pretreatment, endoscope insertion time, endoscopic observation time, endoscope insertion rate, presence or absence of complications accompanying intestinal wash fluid administration, Adenoma detection rate (ADR), polyp detection rate (PDR ), mean number of adenomas per patients (MAP), patient acceptance
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
Picosulfate sodium 0.75% 5 ml oral administration
Interventions/Control_2
Picosulfate sodium 0.75% 5 ml non-oral dosage
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients who need colonoscopy
(2) Patients whose age ranges from 20 to 80
(3) Patients who explained and understood the outline of this research and obtained written informed consent
Key exclusion criteria
(1) Patients who have undergone colon surgery (excluding appendectomy, hemorrhoid surgery, past endoscopic procedures)
(2) Patients with colon lesions for preoperative examination purposes or for endoscopic treatment purposes
(3) Patients with inflammatory bowel disease
(4) Patients with uncontrolled angina, myocardial infarction within the past 3 months, congestive heart failure or uncontrolled hypertension
(5) Patients who allergy of PIcoprep and Picosulfate sodium.
(6) Patients who are not suitable to this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hisabe |
| Middle name | |
| Last name | Takashi |
Organization
Fukuoka University Chikushi Hospital
Division name
Gastroenterology
Zip code
8180067
Address
1-1-1 Zokumyouin, Chikushino City, Fukuoka, Japan
TEL
092-921-1011
hisabe@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Terasawa |
| Middle name | |
| Last name | Masaaki |
Organization
Fukuoka University Chikushi Hospital
Division name
Gastroenterology
Zip code
818-0067
Address
1-1-1 Zokumyouin, Chikushino City, Fukuoka, Japan
TEL
092-921-1011
Homepage URL
masaakiterasawa@gmail.com
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Chikushi Hospital
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
Fukuoka University Chikushi Hospital
Address
1-1-1 Zokumyouin, Chikushino City, Fukuoka, Japan
Tel
092-921-1011
chikushi@adm.fukuoka-u.ac.jp
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
| 2018 | Year | 06 | Month | 26 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 22 | Day |
Last modified on
| 2020 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037649
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
