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
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
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
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
