UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049865 |
|---|---|
| Receipt number | R000056795 |
| Scientific Title | Examination of efficacy and safety of long-term administration of elobixibat in hemodialysis patients with chronic constipation |
| Date of disclosure of the study information | 2022/12/22 |
| Last modified on | 2022/12/22 11:53:43 |
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Basic information
Public title
Examination of efficacy and safety of long-term administration of elobixibat in hemodialysis patients with chronic constipation
Acronym
Examination of efficacy and safety of long-term administration of elobixibat in hemodialysis patients with chronic constipation
Scientific Title
Examination of efficacy and safety of long-term administration of elobixibat in hemodialysis patients with chronic constipation
Scientific Title:Acronym
Examination of efficacy and safety of long-term administration 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
The purpose of this study is to evaluate the efficacy and safety of long-term administration of elobixibat in hemodialysis patients with chronic constipation. In addition, the relationship between the efficacy of elobixibat and the intestinal microbiota will be investigated exploratory.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of spontaneous bowel movement frequency before the start of administration and at the last observation after Week 24 of administration
Key secondary outcomes
1. Comparison of spontaneous bowel movement frequency before and after treatment over time
2. Comparison of the Bristol Stool Form Scale (BSFS) before and after treatment over time
3. Comparison of patient satisfaction before and after treatment over time
4. Comparison of Constipation Scoring System (CSS) before and after treatment over time
5. Comparison of inter-dialysis weight gain before and after treatment over time
6. Comparison of serum phosphorus, potassium, sodium, chloride, calcium, albumin before and after treatment over time
7. Comparison of serum LDL-cholesterol and serum total cholesterol before and after treatment over time 8. Comparison of total lymphocyte counts before and after treatment over time
9. Change of patient satisfaction ("0. Very satisfied" and "1. Satisfied" rates) before and after treatment over time
10. Relationship between patient satisfaction and each efficacy endpoint
11. Comparison of intestinal microbiota in patients with adequate and inadequate response to elobixibat treatment
12. Relationship between intestinal microflora and blood urea toxin
13. Comparison of nutritional indices (albumin, serum total cholesterol, total lymphocyte count, and CONUT score calculated from these indices) in patients with satisfactory response to elobixibat and those with insufficient response
14. Adverse events and adverse drug reactions and their incidence
15. Discontinuation rate
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with 18 years or older
2. Patients with chronic kidney disease who have been on hemodialysis for more than 3 months
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 have received elobixibat for at least 24 weeks according to the dosage and administration during the period under investigation (concomitant use with other laxatives is allowed)
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 who participated in clinical trials or intervention studies during the observation period
Target sample size
55
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
TEL
0947-42-9100
tkfm-shn.3@smile.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Momoko |
| Middle name | |
| Last name | Watanabe |
Organization
SRD Co., Ltd.
Division name
Clinical Research Department
Zip code
104-0032
Address
3-4-8, Hatchobori, Chuo-ku, Tokyo
TEL
03-5543-0302
Homepage URL
md-ex-pro@cro-srd.co.jp
Sponsor or person
Institute
Hyakutake Clinic
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
Maebashi Hirosegawa Clinic IRB
Address
2-10-9 Chiyodamachi, Maebashi-shi, Gunma
Tel
03-5543-0196
jimukyoku@smo-msr.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）/ Hyakutake Clinic (Fukuoka)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 22 | 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 | 12 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: observational study
Observation period: April 19, 2018 - January 31, 2023
Observation and examination items will be obtained from medical records and patient questionnaires for study subjects who received elobixibat at Hyakutake Clinic during the study period to investigate the efficacy and safety of elobixibat.
In addition, fecal samples and blood samples will be collected from study subjects who have been continuously attending the clinic, and the intestinal microflora in the feces and urea toxin derived from intestinal bacteria in the blood will be measured to explore the relationship between the efficacy of elobixibat and the intestinal microflora.
Management information
Registered date
| 2022 | Year | 12 | Month | 22 | Day |
Last modified on
| 2022 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056795
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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