UMIN-CTR Clinical Trial

Basic information
Public title	A randomized double-blind placebo controlled trial on the effect of stimulative laxative and osmotic laxative in patients with chronic constipation
Acronym	Effect of stimulative laxative and osmotic laxative in patients with chronin constipation
Scientific Title	A randomized double-blind placebo controlled trial on the effect of stimulative laxative and osmotic laxative in patients with chronic constipation
Scientific Title:Acronym	Effect of stimulative laxative and osmotic laxative in patients with chronic constipation
Region	Japan

Condition
Condition	Chronic constipation siagnosed by RomeIV criteria
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to evaluate its therapeutic effects of stimulant laxative and osmotic laxative in japanese CC patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	overall improvement over the 4-week study period
Key secondary outcomes	1.spontaneous bowel movement (SBM) 2.complete spontaneous bowel movement (CSBM) 3.stool form 4.abdominal symptom 5.quality of life (QOL)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	alosenn
Interventions/Control_2	magnesium oxide
Interventions/Control_3	placebo
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	Chronic constipation patient aged 20-74 years and diagnosed according to the RomeIV criteria
Key exclusion criteria	Candidates are excluded if they prescribe drug for constipation in hospital or use the over the counter medicines for constipation Everyday Candidates are excluded if they cannot use the over the counter medicines for constipation until fourteen days from consent of this study Candidates are excluded if any of the following are evident: current evidence of renal dysfuncti or cardiac disturbance or hypermagnesemia Secondary constipation candidates are excluded Candidates are excluded if take a madecine of the proton pump inhibitor or the potassium-competitive acid blocher Female patient could not be pregnant,as confirmed by a negative serum pregnancy test at the baseline visit
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Hiroto Middle name Last name Miwa
Organization	Hyogo College of Medicine
Division name	Division of Gastroenterology,Department of Internal Medicine
Zip code	663-8501
Address	1-1,Mukogawa-cho,Nisinomiya,Hyogo 663-8501,Japan
TEL	+81-798-45-6662
Email	miwahgi@hyo-med.ac.jp

Public contact
Name of contact person	1st name Toshihiko Middle name Last name Tomita
Organization	Hyogo College of Medicine
Division name	Division of Gastroenterology,Department of Internal Medicine
Zip code	663-8501
Address	1-1,Mukogawa-cho,Nisinomiya,Hyogo 663-8501,Japan
TEL	+81-798-45-6662
Homepage URL
Email	tomita@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
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	Hyogo College of Medicine
Address	1-1,Mukogawa-cho,Nisinomiya,Hyogo 663-8501,Japan
Tel	+81-798-45-6662
Email	tomita@hyo-med.ac.jp

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	・兵庫医科大学病院（兵庫県） ・医療法人協和会協立病院（兵庫県） ・明和病院（兵庫県） ・西宮協立脳神経外科病院（兵庫県） ・尼崎中央病院（兵庫県） ・大久保病院(兵庫県)

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 15 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	Preinitiation
Date of protocol fixation	2018 Year 09 Month 26 Day
Date of IRB	2018 Year 09 Month 26 Day
Anticipated trial start date	2019 Year 03 Month 15 Day
Last follow-up date	2020 Year 03 Month 15 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 02 Month 29 Day
Date analysis concluded	2020 Year 02 Month 29 Day

Other
Other related information

Management information
Registered date	2019 Year 04 Month 15 Day
Last modified on	2020 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041063