UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014392
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kmabe@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital, Division of Endoscopy
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015699

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.