UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028973
Receipt number R000032674
Scientific Title A randomized double-blind placebo controlled trial on the effect of magnesium oxide in patients with chronic constipation
Date of disclosure of the study information 2017/09/15
Last modified on 2019/03/18 22:38:06

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Basic information

Public title

A randomized double-blind placebo controlled trial on the effect of magnesium oxide in patients with chronic constipation

Acronym

Effect of magnesium oxide in patients with chronic constipation

Scientific Title

A randomized double-blind placebo controlled trial on the effect of magnesium oxide in patients with chronic constipation

Scientific Title:Acronym

Effect of magnesium oxide in patients with chronic constipation

Region

Japan


Condition

Condition

Chronic constipation diadnosed by Rome IV criteria

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy and colonic transit time with the use of magnesium oxide on chronic constipation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

overall treatment efficacy

Key secondary outcomes

1.Monthly responder rates and weekly change from baseline in complete spontaneous bowel movement
2.Monthly responder rates and weekly change from baseline in spontaneous bowel movement
3.colon transit time
4.Bristol stool form
5.The patient assessment of constipation quality of life (JPAC-QOL) and SF-8
6.Weekly change from baselaine in symptom score of bloating
7.Weekly change from baselaine in symptom score of abdominal discomfort
8.Weekly change from baselaine in symptom score of afeeling of remaining faces
9.Weekly change from baselaine in symptom score of severity of straining


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

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

magnesium oxide

Interventions/Control_2

placebo

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

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

34


Research contact person

Name of lead principal investigator

1st name Toshihiko
Middle name
Last name Tomita

Organization

Hypgo College of Medicine

Division name

Division of Gastroenterology,Department of Internal Medicine

Zip code

663-8501

Address

Nishinomiya

TEL

0798456661

Email

tomita@hyo-med.ac.jp


Public contact

Name of contact person

1st name Toshihiko
Middle name
Last name Tomita

Organization

Dr.

Division name

Division of Gastroenterology,Department of Internal Medicine

Zip code

6638501

Address

Nishinomiya

TEL

0798456661

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-chou, Nishinomiya

Tel

0798456661

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



Other administrative information

Date of disclosure of the study information

2017 Year 09 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

2017 Year 08 Month 21 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 15 Day

Last follow-up date

2019 Year 03 Month 18 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 03 Month 18 Day


Other

Other related information



Management information

Registered date

2017 Year 09 Month 02 Day

Last modified on

2019 Year 03 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032674


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name