UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048397 |
|---|---|
| Receipt number | R000055167 |
| Scientific Title | A multicenter prospective study to evaluate the effect of elobixibat on spontaneous defecation without a feeling of residual stool in patients with chronic constipation who are inadequately effective with magnesium oxide, a first-line treatment for constipation. |
| Date of disclosure of the study information | 2022/07/18 |
| Last modified on | 2022/07/18 15:48:32 |
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Basic information
Public title
A multicenter prospective study to evaluate the effect of elobixibat on spontaneous defecation without a feeling of residual stool in patients with chronic constipation who are inadequately effective with magnesium oxide, a first-line treatment for constipation.
Acronym
A multicenter prospective study to evaluate the effect of elobixibat on spontaneous defecation without a feeling of residual stool in patients with chronic constipation who are inadequately effective with magnesium oxide, a first-line treatment for constipation.
Scientific Title
A multicenter prospective study to evaluate the effect of elobixibat on spontaneous defecation without a feeling of residual stool in patients with chronic constipation who are inadequately effective with magnesium oxide, a first-line treatment for constipation.
Scientific Title:Acronym
A multicenter prospective study to evaluate the effect of elobixibat on spontaneous defecation without a feeling of residual stool in patients with chronic constipation who are inadequately effective with magnesium oxide, a first-line treatment for constipation.
Region
| Japan |
Condition
Condition
chronic constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of elobixibat for patients with chronic constipation who are refractory to magnesium oxide
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in spontaneous bowel movements (SBM) before and after switching to study drug
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Orally administer 10 mg of elobixibat once daily before meals.
Interventions/Control_2
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
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Age at the time of consent acquisition is 20 years or older
2) Among those who are refractory to MgO, those with chronic constipation according to the diagnostic criteria for functional constipation of Rome IV
3) Those who start administration of elobixibat in normal medical care
4) Persons who have obtained consent from the research subject
Key exclusion criteria
1) Patients with a history of hypersensitivity to elobixibat
2) Patients with confirmed or suspected intestinal obstruction due to tumor, hernia, etc.
3) Patients suspected of having constipation due to organic disease
4) Patients taking other laxatives
5) Others who are judged by the principal investigator to be inappropriate as research subjects
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Matsumoto |
Organization
Medical corporation Irisawa Medical Clinic
Division name
Internal Medicine
Zip code
690-0025
Address
285-6, Yawata-cho, Matsue 690-0025
TEL
0852-38-8211
matsumotokazuya@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Matsumoto |
Organization
Medical corporation Irisawa Medical Clinic
Division name
Internal Medicine
Zip code
690-0025
Address
285-6, Yawata-cho, Matsue 690-0025
TEL
0852-38-8211
Homepage URL
matsumotokazuya@tottori-u.ac.jp
Sponsor or person
Institute
Medical corporation Irisawa Medical Clinic
Institute
Department
Personal name
Funding Source
Organization
none
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
Tottori University Hospital
Address
36-1 Nishi-cho, Yonago, 683-8504
Tel
0859-38-6527
matsumotokazuya@tottori-u.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
| 2022 | Year | 07 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 18 | Day |
Last modified on
| 2022 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055167
