UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Mototsugu Kato
Organization	Hokkaido University Hospital
Division name	Division of Endoscopy
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	Katsuhiro Mabe
Organization	Hokkaido University Hospital
Division name	Division of Endoscopy
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000015699