UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020904
Receipt number 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 2021/10/19 23:03:27

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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 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 or person

Institute

Takamatsu Red Cross Hospital

Institute

Department

Personal name



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

Value
https://center6.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