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
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
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
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 | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
