UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000036519
Receipt number R000041063
Scientific Title A randomized double-blind placebo controlled trial on the effect of stimulative laxative and osmotic laxative in patients with chronic constipation
Date of disclosure of the study information 2019/04/15
Last modified on 2020/03/07 12:13:56

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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 or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041063


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name