UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039634 |
|---|---|
| Receipt number | R000045205 |
| Scientific Title | Efficacy of erobixibat in patients with chronic constipation, examination of factors related to efficacy. |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2020/02/28 17:05:38 |
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Basic information
Public title
A study on the efficacy of erobixibat in patients with chronic constipation
Acronym
erobixibat trial
Scientific Title
Efficacy of erobixibat in patients with chronic constipation, examination of factors related to efficacy.
Scientific Title:Acronym
A study on the efficacy of erobixibat in patients with chronic constipation
Region
| Japan |
Condition
Condition
chronic constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the factors related to the efficacy of erobixibat among chronic constipation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between effective and non-effective cases of erobixibat and patient background factors (age, gender, frequency of bile acid transporter expression in terminal ileum, SNP type)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
When two or more of the following symptoms persist for 3 months or more
a) less than 3 spontaneous bowels per week
b) More than 25% of the stools are active
c) Rabbit stool or hard stool is present in at least 25% of the bowel movement
d) 25% or more of bowel movements have a feeling of residual stool
d) Over 25% of bowel movements have rectal anal obstruction
e) More than 25% of defecations have manual defecation
promotion measures
Key exclusion criteria
(1) Intestinal obstruction due to tumor, hernia, etc. is confirmed or suspected.
(2) When taking digoxin or dabigatran etexilate methanesulfonate (since these effects may be enhanced when used in combination)
(3) Patients who did not agree to participate in this clinical trial
(4) Those who are judged to be inappropriate as subjects by the principal investigator
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Chika |
| Middle name | |
| Last name | Kusano |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
1018309
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
0332931711
ckusano2007@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Kusano |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
1018309
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
0332931711
Homepage URL
ckusano2007@yahoo.co.jp
Sponsor or person
Institute
Nihon University School of Medicine, Division of Gastroenterology and Hepatology, Department of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine, Division of Gastroenterology and Hepatology, Department of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Medicine, Division of Gastroenterology and Hepatology, Department of Medicine
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
Tel
0332931711
ckusano2007@yahoo.co.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
| 2020 | Year | 03 | Month | 01 | 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
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observation study.
We will entry a patient diagnosed with chronic constipation
in the Nihon University Hospital within the applicable period.
Management information
Registered date
| 2020 | Year | 02 | Month | 28 | Day |
Last modified on
| 2020 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045205
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
