UMIN-CTR Clinical Trial

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 Hiroyuki Middle name Last name Tamaki
Organization	Takamatsu Redcross Hospital
Division name	Gastroenterology
Zip code	7600017
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 Hiroyuki Middle name Last name Tamaki
Organization	Takamatsu Redcross Hospital
Division name	Gastroenterology
Zip code	7600017
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 Red Cross Hospital
Institute
Department

Funding Source
Organization	Takamatsu Red Cross 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	Takamatsu Red Cross Hospital
Address	4-1-3, Ban-cho, Takamatsu, Kagawa, Japan
Tel	+819039491876
Email	tamaki33@gmail.com

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	Main results already published
Date of protocol fixation	2014 Year 10 Month 01 Day
Date of IRB	2014 Year 09 Month 04 Day
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	2021 Year 10 Month 19 Day

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