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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020904
Receipt No. R000024116
Scientific Title 1.2L polyethylene glycol + ascorbic acid versus 2.0L polyethylene glycol-electrolyte acid for outpatient bowel preparation.
Date of disclosure of the study information 2016/02/08
Last modified on 2016/08/08

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Basic information
Public title 1.2L polyethylene glycol + ascorbic acid versus 2.0L polyethylene glycol-electrolyte acid for outpatient bowel preparation.
Acronym 1.2L polyethylene glycol + ascorbic acid versus 2.0L polyethylene glycol-electrolyte acid for outpatient bowel preparation.
Scientific Title 1.2L polyethylene glycol + ascorbic acid versus 2.0L polyethylene glycol-electrolyte acid for outpatient bowel preparation.
Scientific Title:Acronym 1.2L polyethylene glycol + ascorbic acid versus 2.0L polyethylene glycol-electrolyte acid for outpatient bowel preparation.
Region
Japan

Condition
Condition Colon diseases (Patients undergoing routine total colonoscopy)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of 1.2L polyethylene glycol + ascorbic acid compared with 2.0L polyethylene glycol-electrolyte for outpatient bowel preparation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Degree of colon cleansing assessed by Boston Bowel Preparation Scale (BBPS) and an original scoring system.
Key secondary outcomes Volume of fluid intake, required time to bowel preparation, result of questionnaire on acceptability and evaluation for safety.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 On the day before colonoscopy: 48mg of sennoside once at bedtime.
On the day of colonoscopy: 1.2L of polyethylene glycol + ascorbic acid (Moviprep; Ajinomoto Ltd, Tokyo, Japan; composed of 200g of macrogol 4000, electrolytes and 9.400g ascorbic acid) diluted into 2.0L of plain water and at least 0.6L of additional clear fluid.
Interventions/Control_2 On the day before colonoscopy: 48mg of sennoside once at bedtime.
On the day of colonoscopy: 2.0L of polyethylene glycol-electrolyte (Nifrec; Ajinomoto Ltd, Tokyo, Japan; composed of macrogol 4000 and electrolytes) diluted into 2.0L of plain water.
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
18 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with an appropriate indication to colonoscopy.
Key exclusion criteria 1. Patients who have known or suspected bowel obstruction or ileus.
2. Patients who have known or suspected perforation.
3. Patients who have significant gastroparesis or gastric outlet obstruction.
4. Patients with severe chronic renal failure (creatinine clearance <30 mL/minute) and severe congestive heart failure (New York Heart Association [NYHA] class III or IV).
5. Patients with sustained tachyarrhythmia.
6. Patients with uncontrolled hypertension (systolic blood pressure >170 mm Hg, diastolic blood pressure >100mmHg).
7. Patients with toxic colitis or megacolon.
8. Pregnant or lactating women.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Tamaki
Organization Takamatsu Redcross Hospital
Division name Gastroenterology
Zip code
Address 4-1-3, Ban-cho, Takamatsu, Kagawa
TEL 087-831-7101
Email h-tama@gc4.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Tamaki
Organization Takamatsu Redcross Hospital
Division name Gastroenterology
Zip code
Address 4-1-3, Ban-cho, Takamatsu, Kagawa
TEL 087-837-7101
Homepage URL
Email h-tama@gc4.so-net.ne.jp

Sponsor
Institute Takamatsu Redcross Hospital
Institute
Department

Funding Source
Organization Takamatsu Redcross 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
Address
Tel
Email

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 高松赤十字病院(香川県)

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 08 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
2014 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 31 Day
Last follow-up date
2016 Year 07 Month 25 Day
Date of closure to data entry
2016 Year 07 Month 25 Day
Date trial data considered complete
2016 Year 07 Month 25 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 05 Day
Last modified on
2016 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024116

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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