UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049639 |
|---|---|
| Receipt number | R000056530 |
| Scientific Title | Examination of efficacy and safety of elobixibat in patients with chronic constipation by combination with or switching from existing therapy - A Retrospective Observational Study- |
| Date of disclosure of the study information | 2022/11/29 |
| Last modified on | 2024/08/28 13:45:20 |
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Basic information
Public title
Examination of efficacy and safety of elobixibat in patients with chronic constipation by combination with or switching from existing therapy - A Retrospective Observational Study-
Acronym
Examination of efficacy and safety of elobixibat in patients with chronic constipation by combination with or switching from existing therapy - A Retrospective Observational Study-
Scientific Title
Examination of efficacy and safety of elobixibat in patients with chronic constipation by combination with or switching from existing therapy - A Retrospective Observational Study-
Scientific Title:Acronym
Examination of efficacy and safety of elobixibat in patients with chronic constipation by combination with or switching from existing therapy - A Retrospective Observational Study-
Region
| Japan |
Condition
Condition
Chronic Constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of elobixibat when administered in combination with or switching from existing therapies (e.g., magnesium oxide) in patients with chronic constipation who are judged to be inadequately response to existing therapies alone in terms of efficacy and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of spontaneous bowel movements before and 2 weeks after elobixibat treatment
Key secondary outcomes
1. Stool shape (Bristol Stool form Scale) before and after 2 weeks of treatment
2. Comparison of sensation of incomplete evacuation before and after 2 weeks of treatment
3. Comparison of presence/absence of straining before and after 2 weeks of treatment
4. Comparison of abdominal pain before and after 2 weeks of treatment
5. Comparison of abdominal bloating before and after 2 weeks of treatment
6. Comparison of anorectal blockage before and after 2 weeks of treatment
7. Comparison of nausea before and after 2 weeks of treatment
8. By patient background, elobixibat administration status, and previous or concomitant treatment for constipation subgroup analysis
9. Adverse events and adverse drug reactions and their incidence
10. Discontinuation rate of elobixibat
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. Men and women 18 years of age or older at the time of starting treatment with elobixibat.
2. Patients who are judged by the physician to be inadequate for treatment with existing therapies alone in terms of efficacy and safety.
3. Patients with chronic constipation who meet RomeIV criteria at the start of treatment with elobixibat.
4. Patients who were prescribed an existing therapy for at least 1 week and then started on elobixibat during the study period, either by combination with or switching from an existing therapy.
5. Patients who have a record of treatment progress for at least 2 weeks after elobixibat administration and a record of bowel movements before and after elobixibat administration during the study period.
Key exclusion criteria
1. Patients with contraindications to elobixibat or who were prescribed elobixibat outside the approved indications, dosage and administration during the observation period.
2. Patients who participated in clinical trials or interventional studies during the observation period.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Eguchi |
Organization
Shiga University of Medical Science Hospital
Division name
Department of General Medicine
Zip code
520-2192
Address
Seta Tsukinowacho, Otsu-Shi, Shiga
TEL
077-548-2111
egugu0515@yahoo.co.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-retro@cro-srd.co.jp
Sponsor or person
Institute
Osaka Saiseikai Nakatsu 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
Ethics Committee of Osaka Saiseikai Nakatsu Hospital
Address
2-10-39 Shibata, Kita-ku, Osaka-shi, Osaka
Tel
06-6372-0333
d_torii@nakatsu.saiseikai.or.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
大阪府済生会中津病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 29 | Day |
Related information
URL releasing protocol
protocol is unpublished
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/jgh3.70019
Number of participants that the trial has enrolled
311
Results
Elobixibat was effective in patients refractory to other laxatives, irrespective of previous therapy or patient characteristics. Elobixibat may contribute to resolving polypharmacy with single-action laxatives.
Results date posted
| 2024 | Year | 08 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 08 | Month | 26 | Day |
Baseline Characteristics
The mean age was 74.5 +- 13.3 years, men accounted for 51.1% of the patients (159/311 patients), and the mean duration of CC was 1.4 +- 2.5 years. The mean number of types of prior laxatives was 2.4 +- 1.3 and conditions were present in 95.8% (298/311) of the patients.
Participant flow
Of 844 patients who received elobixibat at the hospital between April 19, 2018 and June 30, 2022, 311 patients were enrolled, excluding 453 patients with missing data for the frequency of bowel movements before and after elobixibat and 80 patients who had not previously used prescribed laxatives.
Adverse events
The incidence of adverse events was 6.1% (19/311 patients, 20 events), comprising 3.9% (12/311) diarrhea, 1.6% (5/311) abdominal pain, 0.6% (2/311) abdominal distention, and 0.3% (1/311) nausea.
Outcome measures
Following elobixibat treatment, the mean weekly SBM rate increased significantly from 2.9 +- 1.9 times/week at baseline to 4.3 +- 1.9 times/week at Week 2 (p<0.0001). The mean BSFS score improved significantly from 3.2 +- 1.7 at baseline to 4.4 +- 1.4 at Week 2 (p<0.0001), with a decrease and an increase in the percentages of patients with hard stools and normal stools, respectively. Improvements in the sensation of incomplete bowel evacuation, straining, abdominal pain and distention, and difficulty defecating were statistically significant (p<0.05). Constipation symptoms were improved irrespective of patient characteristics or previous therapy. On average, 43.9% of previously used laxatives were discontinued at the start of or after starting elobixibat treatment. The treatment was well tolerated.
Plan to share IPD
undecided
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 15 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 07 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 15 | Day |
Other
Other related information
Study design: retrospective observational study
Observation period: April 19, 2018 - June 30, 2022
Observation items will be obtained from medical records of study subjects who received elobixibat in combination with or switched from existing therapies at our hospital during the observation period to evaluate the efficacy and safety of elobixibat.
Management information
Registered date
| 2022 | Year | 11 | Month | 29 | Day |
Last modified on
| 2024 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056530
