UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014392 |
|---|---|
| Receipt number | R000015699 |
| Scientific Title | The efficacy and safety of a hypertonic polyethylene glycol - electrolyte lavage solution (PEG-ELS) for patients with constipated patients or regularly user of a laxative: a randomized study |
| Date of disclosure of the study information | 2014/06/26 |
| Last modified on | 2016/11/10 09:39:31 |
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Basic information
Public title
The efficacy and safety of a hypertonic polyethylene glycol - electrolyte lavage solution (PEG-ELS) for patients with constipated patients or regularly user of a laxative: a randomized study
Acronym
The efficacy and safety of a hypertonic polyethylene glycol - electrolyte lavage solution (PEG-ELS).
Scientific Title
The efficacy and safety of a hypertonic polyethylene glycol - electrolyte lavage solution (PEG-ELS) for patients with constipated patients or regularly user of a laxative: a randomized study
Scientific Title:Acronym
The efficacy and safety of a hypertonic polyethylene glycol - electrolyte lavage solution (PEG-ELS).
Region
| Japan |
Condition
Condition
Patients with chronic constipation, functional constipation or regularly use of a laxative
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of a hypertonic PEG-ELS for patients with constipated patients or regularly user of a laxative compared with a conventional PEG-ELS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of poor colon preparation(Ottawa bowel preparation scale>2) and rate of the patients who needed the enema .
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
A hypertonic PEG-ELS is administrated for colonoscopy bowel preparation.
Interventions/Control_2
A conventional PEG-ELS is administrated for colonoscopy bowel preparation.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patients with chronic constipation or functional constipation.
(2) 20years or older and up to 80 years old.
(3) Patients judged to resect polyp in total colonoscopy within the past two years, and undergoing polypectomy.
(4) )Written informed consent obtained.
Key exclusion criteria
(1) Patients with a history of gastrointestinal tractresection (excluding appendicectomy)
(2) Patients required for colonic ESD
(3) Patients who may have ileus
(4) Patients who have a history of perforation and may have perforation of gastrointestinal tract
(5) Patients with failure of gastric empty
(6) Patients with toxic megacolon
(7) Patients with a history of hypersensitivity to composition of a PEG-ELS or Moviprep
(8) Patients with nausea and vomiting
(9) Patients who request to increase dose of a laxative which is taken commonly from obtaining informed consent to the day before preparation
(10)Patients who may be admitted for purposes of other than polypectomy
(11) Patients who are considered to be unsuitable by the trial investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mototsugu Kato |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
Address
North 14, West 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL
+81-11-716-1161
m-kato@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Mabe |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
Address
Kita14,Nishi5,Kita-ku,Sapporo
TEL
+81-11-716-1161
Homepage URL
kmabe@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital, Division of Endoscopy
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital, Division of Endoscopy
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
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
| 2014 | Year | 06 | Month | 26 | 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 | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 26 | Day |
Last modified on
| 2016 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015699
