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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001566 |
Receipt No. | R000001859 |
Scientific Title | A Randomized, Cross Over Study Comparing The Patient Acceptance of Sodium Phosphate Tablet With 2L Polyethylene Glycol Solution Plus Sodium Picosulfate Solution for Colon Cleansing. |
Date of disclosure of the study information | 2008/12/11 |
Last modified on | 2016/02/18 |
Basic information | ||
Public title | A Randomized, Cross Over Study Comparing The Patient Acceptance of Sodium Phosphate Tablet With 2L Polyethylene Glycol Solution Plus Sodium Picosulfate Solution for Colon Cleansing. | |
Acronym | A Randomized, Cross Over Study Comparing The Patient Acceptance of Sodium Phosphate Tablet With 2L Polyethylene Glycol Solution Plus Sodium Picosulfate Solution for Colon Cleansing. | |
Scientific Title | A Randomized, Cross Over Study Comparing The Patient Acceptance of Sodium Phosphate Tablet With 2L Polyethylene Glycol Solution Plus Sodium Picosulfate Solution for Colon Cleansing. | |
Scientific Title:Acronym | A Randomized, Cross Over Study Comparing The Patient Acceptance of Sodium Phosphate Tablet With 2L Polyethylene Glycol Solution Plus Sodium Picosulfate Solution for Colon Cleansing. | |
Region |
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Condition | |||
Condition | Colonic disorder | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To compare the patient acceptance of sodium phosphate tablet With 2L polyethylene glycol solution plus sodium picosulfate solution for colon cleansing by cross over design. |
Basic objectives2 | Others |
Basic objectives -Others | Quality of colon clensing and Frequency of adverse event(abdominalpain,nausea,bloating etc.) |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase |
Assessment | |
Primary outcomes | patient acceptance |
Key secondary outcomes | Quality of colon clensing and Frequency of adverse event(abdominalpain,nausea,bloating etc.) |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -but assessor(s) are blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | YES |
Concealment | Numbered container method |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | GroupA: 2L Polyethylene glycol solution plus Sodium picosulfate solution for first time colonoscopy and Sodium Phosphate Tablet for for second time colonoscopy. | |
Interventions/Control_2 | GroupB: Sodium Phosphate Tablet for first time colonoscopy and 2L Polyethylene glycol solution plus Sodium picosulfate solution for for second time colonoscopy. | |
Interventions/Control_3 | ||
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Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patient who require colonoscpy two or more times within one year.
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Key exclusion criteria | 1.Patient who have contraindication to NaP tablet and PEG solution.
2.Patient who is in active stage of inflammatory bowel disease. 3.Patient who have dysphagia. 4.Patient who is after colonic operation. |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Keio University | ||||||
Division name | Division of Gastroenterology | ||||||
Zip code | |||||||
Address | 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan | ||||||
TEL | 03-3353-1211 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Keio University | ||||||
Division name | Division of Gastroenterology | ||||||
Zip code | |||||||
Address | 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan | ||||||
TEL | 03-3353-1211 | ||||||
Homepage URL | |||||||
hosenao@db3.so-net.ne.jp |
Sponsor | |
Institute | Division of Gastroenterology,Department of Internal Medicine, Keio University |
Institute | |
Department |
Funding Source | |
Organization | Division of Gastroenterology,Department of Internal Medicine, Keio University |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | Hosoe N, et al. Comparison of patient acceptance of sodium phosphate versus polyethylene glycol plus sodium picosulfate for colon cleansing in Japanese. J Gastroenterol Hepatol. 2012 Oct;27(10):1617-22. |
Results date posted | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Date trial data considered complete |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001859 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |