UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037285 |
|---|---|
| Receipt number | R000042502 |
| Scientific Title | Efficacy and safety of elobixibat in hemodialysis patients with chronic constipation |
| Date of disclosure of the study information | 2019/07/05 |
| Last modified on | 2020/01/06 11:48:47 |
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Basic information
Public title
Efficacy and safety of elobixibat in hemodialysis patients with chronic constipation -Retrospective observation research-
Acronym
Efficacy and safety of elobixibat in hemodialysis patients with chronic constipation
Scientific Title
Efficacy and safety of elobixibat in hemodialysis patients with chronic constipation
Scientific Title:Acronym
Efficacy and safety of elobixibat in hemodialysis patients with chronic constipation
Region
| Japan |
Condition
Condition
Chronic constipation complicated with chronic renal disease
Classification by specialty
| Gastroenterology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of elobixibat in hemodialysis patients with chronic constipation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of frequency of spontaneous bowel movement between baseline and week 12 of administration
Key secondary outcomes
Changes in the frequency of spontaneous bowel movements during 12 weeks
Changes in the Bristol Stool Form Scales during 12 weeks
and comparison between baseline to at weeks 12 of administration
Comparison in the patient satisfaction (VAS) between baseline and at weeks 12 of administration
Comparison in the Constipation Scoring System between baseline and at weeks 12 of administration
Changes in the body weight gain of interdialytic period per week during 12 weeks and comparison between baseline and at weeks 12 of administration
Changes in the concentration of serum phosphorus, potassium, sodium, chloride, calcium, albumin during 12 weeks and comparison between baseline and at weeks 12 of administration
Comparison in the concentration of serum LDL-cholesterol between baseline and at weeks 12 of administration
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with 20 years or older
2. Patients more than 6 months after hemodialysis introduction
3. Patients with chronic constipation who must include 2 or more the following 6 items
a. Straining during more than one-fourth of defecations
b. Lumpy or hard stools (BSFS 1or 2) more than one-fourth of defecations
c. Sensation of incomplete evacuation more than one-fourth of defecations
d.Sensation of anorectal obstruction/blockage more than
one-fourth of defecations
e. Manual maneuvers to facilitate more than one fourth of defecations
f. Fewer than 3 spontaneous bowel movements per week 4. Patients who starts Elobixibat administration from April 19, 2018 to January 18, 2019
Key exclusion criteria
1. Patients who had a history of hypersensitivity of elobixibat
2. Patients who are confirmed or suspected intestinal obstruction due to tumor, hernia etc
3. Patients who are suspected constipation due to organic disease
4. Patients whose physicians judged that administration of elobixibat was inappropriate
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Takefumi |
| Middle name | |
| Last name | Shono |
Organization
Hyakutake Clinic
Division name
Vice-principal
Zip code
825-0001
Address
2195-26, Ikari, Tagawa Shi, Fukuoka Ken, Japan
TEL
0947-42-9100
tkfm-shn.3@smile.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Takefumi |
| Middle name | |
| Last name | Shono |
Organization
Hyakutake Clinic
Division name
Vice-principal
Zip code
825-0001
Address
2195-26, Ikari, Tagawa Shi, Fukuoka Ken, Japan
TEL
0947-42-9100
Homepage URL
tkfm-shn.3@smile.ocn.ne.jp
Sponsor or person
Institute
Hyakutake Hospital
Institute
Department
Personal name
Funding Source
Organization
MOCHIDA PHARMACEUTICAL CO.,LTD. , EA Pharma Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamauchi Clinic IRB
Address
1-15-19, Jiyugaoka, Meguro Ku, Tokyo To, Japan
Tel
03-5575-5862
c-irb_ug@neues.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
医療法人 百武医院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 05 | 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
23
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
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 10 | Month | 17 | Day |
Other
Other related information
nothing
Management information
Registered date
| 2019 | Year | 07 | Month | 05 | Day |
Last modified on
| 2020 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042502
