Back to resultsElobixibat for Chronic Constipation Without Defecation Desire (R-LODD)
Primary Purpose
Chronic Constipation
Status
Recruiting
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Elobixibat 10mg
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Constipation
Eligibility Criteria
Inclusion Criteria:
At the time of provisional registration
- Patients diagnosed with chronic constipation using the Rome IV criteria for the diagnosis of chronic constipation
- Age: 20 years or older (at the time of obtaining consent)
- Gender: Any
- outpatients
- Patients for whom written consent can be obtained
- Patients who can record defecation, etc. in the patient diary
At the time of registration: Dosing start criteria Patients with the following ・'Loss of defecation desire'* in the second week of the observation period (1 week before the start of the treatment period)
*"Loss of defecation desire " refers to patients whose "presence or absence of defecation desire" on the patient questionnaire was "4. almost never" or "5. never".
Exclusion Criteria:
At the time of temporary registration Exclude patients with any of the following conditions
- Patients with organ-related constipation or suspected of having organ-related constipation
- Patients with or suspected of having functional ileus
- Patients with or suspected of having inguinal hernia
- Patients with a history of open abdominal surgery within 12 weeks prior to obtaining consent (excluding appendicitis resection)
- Patients with a history of surgical or endoscopic procedures related to gallbladder resection and papillotomy
- Patients with complications of malignancy However, patients who have undergone radical surgery or who have completed chemotherapy or radiotherapy may be registered.
- Pregnant women, lactating women, women who may be currently pregnant, or patients who cannot give consent to use contraception while participating in the study
- Patients with serious renal, hepatic, or cardiac disease
- Patients with drug allergy to the study drug
- Patients who are participating in other clinical studies, or who have participated in other clinical studies within 4 weeks prior to obtaining consent However, observational studies are excluded.
- Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for this study.
At the time of registration: Dosing start criteria
- Patients who increased the dose of concomitantly restricted drugs during the observation period
- Patients who used concomitantly prohibited drugs during the observation period
Sites / Locations
- Yokohama City UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Elobixibat
Arm Description
10mg Elobixibat administration for 4 weeks
Outcomes
Primary Outcome Measures
Percentage of change in loss of defecation desire
Percentage of change in loss of defecation desire in the fourth week of the treatment period from the second week of the observation period (patient questionnaire). The presence or absence of defecation desire was assessed using a 5-point scale on the patient questionnaire: 1. always, 2. almost always, 3. a little, 4. almost never, 5. never.
Secondary Outcome Measures
Presence of defecation desire
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire). The presence or absence of defecation desire was assessed using a 5-point scale on the patient questionnaire: 1. always, 2. almost always, 3. a little, 4. almost never, 5. never.
Satisfaction with defecation desire
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Satisfaction of straining
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period(patient questionnaire).
Degree of straining
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period(patient questionnaire).
Presence of a sense of incomplete evacuation
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Satisfaction with treatment
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Spontaneous bowel movement (SBM) frequency
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient daily).
Complete Spontaneous Bowel Movement (CSBM) frequency
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient daily).
Stool hardness based on the Bristol Stool Form Scale
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Constipation severity score
Comparison of the Constipation severity score at Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Japanese version of the Patient Assessment of Constipation Quality of Life
Comparison of the Japanese version of the Patient Assessment of Constipation Quality of Life questionrair at Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Change of bile acid cocentration
Comparison of the bile acid concentration at Week 4 of the treatment period with Week 2 of the observation period (serum and feces).
Change in defecation time.
Changes in the time from taking elobixibat to defecation each week during the treatment period
Full Information
NCT ID
NCT05165199
First Posted
December 4, 2021
Last Updated
March 21, 2022
Sponsor
Yokohama City University
1. Study Identification
Unique Protocol Identification Number
NCT05165199
Brief Title
Elobixibat for Chronic Constipation Without Defecation Desire
Acronym
R-LODD
Official Title
A Multicenter, Single-group, Open-label, Before-and-after Study Confirming Recovery of Defecation Desire by Administration of Elobixibat in Patients With Chronic Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yokohama City University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients of chronic constipation without defecation desire will be orally administered elobixibat 10 mg once daily before meals for 4 weeks. The primary endpoint of the pre/post comparative study will be the percentage of improvement in bowel movements from Week 2 of the observation period at Week 4 of the treatment period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Elobixibat
Arm Type
Experimental
Arm Description
10mg Elobixibat administration for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Elobixibat 10mg
Intervention Description
Patients of chronic constipation with loss of defecation desire are administered Elobixibat 10mg for 4 weeks
Primary Outcome Measure Information:
Title
Percentage of change in loss of defecation desire
Description
Percentage of change in loss of defecation desire in the fourth week of the treatment period from the second week of the observation period (patient questionnaire). The presence or absence of defecation desire was assessed using a 5-point scale on the patient questionnaire: 1. always, 2. almost always, 3. a little, 4. almost never, 5. never.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Presence of defecation desire
Description
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire). The presence or absence of defecation desire was assessed using a 5-point scale on the patient questionnaire: 1. always, 2. almost always, 3. a little, 4. almost never, 5. never.
Time Frame
Week 4
Title
Satisfaction with defecation desire
Description
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Time Frame
Week 4
Title
Satisfaction of straining
Description
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period(patient questionnaire).
Time Frame
Week 4
Title
Degree of straining
Description
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period(patient questionnaire).
Time Frame
Week 4
Title
Presence of a sense of incomplete evacuation
Description
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Time Frame
Week 4
Title
Satisfaction with treatment
Description
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Time Frame
Week 4
Title
Spontaneous bowel movement (SBM) frequency
Description
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient daily).
Time Frame
Week 4
Title
Complete Spontaneous Bowel Movement (CSBM) frequency
Description
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient daily).
Time Frame
Week 4
Title
Stool hardness based on the Bristol Stool Form Scale
Description
Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Time Frame
Week 4
Title
Constipation severity score
Description
Comparison of the Constipation severity score at Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Time Frame
Week 4
Title
Japanese version of the Patient Assessment of Constipation Quality of Life
Description
Comparison of the Japanese version of the Patient Assessment of Constipation Quality of Life questionrair at Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Time Frame
Week 4
Title
Change of bile acid cocentration
Description
Comparison of the bile acid concentration at Week 4 of the treatment period with Week 2 of the observation period (serum and feces).
Time Frame
Week 4
Title
Change in defecation time.
Description
Changes in the time from taking elobixibat to defecation each week during the treatment period
Time Frame
Week 4
Other Pre-specified Outcome Measures:
Title
Incidence rate of diseases
Description
Safety assessment
Time Frame
Week 0-4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At the time of provisional registration
Patients diagnosed with chronic constipation using the Rome IV criteria for the diagnosis of chronic constipation
Age: 20 years or older (at the time of obtaining consent)
Gender: Any
outpatients
Patients for whom written consent can be obtained
Patients who can record defecation, etc. in the patient diary
At the time of registration: Dosing start criteria Patients with the following ・'Loss of defecation desire'* in the second week of the observation period (1 week before the start of the treatment period)
*"Loss of defecation desire " refers to patients whose "presence or absence of defecation desire" on the patient questionnaire was "4. almost never" or "5. never".
Exclusion Criteria:
At the time of temporary registration Exclude patients with any of the following conditions
Patients with organ-related constipation or suspected of having organ-related constipation
Patients with or suspected of having functional ileus
Patients with or suspected of having inguinal hernia
Patients with a history of open abdominal surgery within 12 weeks prior to obtaining consent (excluding appendicitis resection)
Patients with a history of surgical or endoscopic procedures related to gallbladder resection and papillotomy
Patients with complications of malignancy However, patients who have undergone radical surgery or who have completed chemotherapy or radiotherapy may be registered.
Pregnant women, lactating women, women who may be currently pregnant, or patients who cannot give consent to use contraception while participating in the study
Patients with serious renal, hepatic, or cardiac disease
Patients with drug allergy to the study drug
Patients who are participating in other clinical studies, or who have participated in other clinical studies within 4 weeks prior to obtaining consent However, observational studies are excluded.
Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for this study.
At the time of registration: Dosing start criteria
Patients who increased the dose of concomitantly restricted drugs during the observation period
Patients who used concomitantly prohibited drugs during the observation period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takaomi Kessoku, M.D., PhD.
Phone
+81-45-787-2800
Ext
2640
Email
takaomi0027@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Atsushi Nakajima, M.D., PhD.
Phone
+81-45-787-2800
Ext
2640
Email
nakajima-tky@umin.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takaomi Kessoku, M.D., PhD.
Organizational Affiliation
Yokohama City University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yokohama City University
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takaomi Kessoku, MD., PhD.
Phone
+81-45-787-2800
Ext
2640
Email
kessoku-tho@umin.ac.jp
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32858571
Citation
Ohkubo H, Takatsu T, Yoshihara T, Misawa N, Ashikari K, Fuyuki A, Matsuura T, Higurashi T, Yamamoto K, Matsumoto H, Odaka T, Lembo AJ, Nakajima A. Difference in Defecation Desire Between Patients With and Without Chronic Constipation: A Large-Scale Internet Survey. Clin Transl Gastroenterol. 2020 Sep;11(9):e00230. doi: 10.14309/ctg.0000000000000230.
Results Reference
background
PubMed Identifier
35812817
Citation
Yamamoto A, Kessoku T, Tanaka K, Takahashi K, Kasai Y, Ozaki A, Iwaki M, Kobayashi T, Yoshihara T, Misawa N, Ohkuma K, Fuyuki A, Higurashi T, Hosono K, Yoneda M, Iwasaki T, Kurihashi T, Nakatogawa M, Suzuki A, Taguri M, Oyamada S, Ariyoshi K, Kobayashi N, Ichikawa Y, Nakajima A. Rationale and design of a multicenter, single-group, open-label trial aiming at investigating the effectiveness of elobixibat for loss of defecation desire in patients with chronic constipation. Contemp Clin Trials Commun. 2022 Jun 27;28:100958. doi: 10.1016/j.conctc.2022.100958. eCollection 2022 Aug.
Results Reference
derived
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Elobixibat for Chronic Constipation Without Defecation Desire
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