UMIN-CTR 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
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
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
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/ctr_e/ctr_view.cgi?recptno=R000041063
