UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023529 |
|---|---|
| Receipt number | R000027099 |
| Scientific Title | A Randomized study comparing reduced dose of sodium phosphate tablets with 2 L polyethylene glycol for preparation of colonoscopy |
| Date of disclosure of the study information | 2016/08/10 |
| Last modified on | 2016/08/07 14:12:19 |
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Basic information
Public title
A Randomized study comparing reduced dose of sodium phosphate tablets with 2 L polyethylene glycol for preparation of colonoscopy
Acronym
A Randomized study of reduced dose of sodium phosphate tablets with 2 L polyethylene glycol
Scientific Title
A Randomized study comparing reduced dose of sodium phosphate tablets with 2 L polyethylene glycol for preparation of colonoscopy
Scientific Title:Acronym
A Randomized study of reduced dose of sodium phosphate tablets with 2 L polyethylene glycol
Region
| Japan |
Condition
Condition
Patients who need the examination of colonoscopy
Classification by specialty
| Medicine in general | Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The comparison of patients acceptance and bowel cleansing quality between reduced dose of sodium phosphate tablets and 2 L polyethylene glycol
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients acceptance and bowel cleansing quolity of reduced dose of sodium phosphate tablets with 2 L polyethylene glycol
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
The day before colonoscopy:patients received 20 mL of 0.75% sodium picosulfate.
On the morning of colonoscopy:patients are requested to take 30g of sodium phosphate tablets with 2 L of water/tea, or drink 2 L of polyethylene glycol
Interventions/Control_2
The day before colonoscopy:patients received 20 mL of 0.75% sodium picosulfate.
On the morning of colonoscopy:patients are requested to take 30g of sodium phosphate tablets with 2 L of water/tea, or drink 2 L of polyethylene glycol
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who need to recieve the examination of colonoscopy
Key exclusion criteria
under 20 years of age, over 64 years of age, the presence of bowel obstruction, renal failure, uncontrollable hypertension, and hypersensitivity to sodium phosphate tablets or polyethylene glycol
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soichiro Ako |
Organization
Tsuyama Chuo Hospital
Division name
Gastrointestinal Endoscopy Center
Zip code
Address
1756 Kawasaki Tsuyama City Okayama Prefecture Japan
TEL
0868-21-8111
soichiro.ako@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soichiro Ako |
Organization
Tsuyama Chuo Hospital
Division name
Gastrointestinal Endoscopy Center
Zip code
Address
1756 Kawasaki Tsuyama City Okayama Prefecture Japan
TEL
0868-21-8111
Homepage URL
soichiro.ako@gmail.com
Sponsor or person
Institute
Tsuyama Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsuyama Chuo Hospital
Organization
Division
Category of Funding Organization
Other
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
津山中央病院(岡山県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 10 | 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
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 07 | Day |
Last modified on
| 2016 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027099
