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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028973
Receipt No. 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

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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
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-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
URL(English) https://upload.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


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