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Long-term Elobixibat for Chronic Constipation (TANK-27)

Primary Purpose

Chronic Constipation

Status
Recruiting
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Elobixibat 10mg
Placebo
Sponsored by
Yokohama City University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Constipation focused on measuring Elobixibat, Chronic constipation, 12 week, Complete spontaneous bowel movement

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with chronic constipation by the "Rome IV" criteria for chronic constipation
  • Age: 20 years old or older and up to 85 years old (at the time of obtaining consent)
  • Gender: any gender
  • outpatients
  • Patients who can obtain written consent
  • Patients who can record their defecation, etc. in the patient's diary

At the time of allocation (dosing initiation criteria)

  • Spontaneous bowel movements (SBM)* not more than 6 times during the 2-week observation period before the start of treatment
  • Patients with no soft or watery stools (Bristol Stool Shape Scale 6 or 7) in spontaneous bowel movements during the 2-week observation period before the start of treatment.
  • Patients who have not used concomitantly prohibited drugs or therapies during the observation period.

Exclusion Criteria:

  • Patients with organic constipation or patients with suspected organic constipation.
  • Patients with or suspected of having functional ileus.
  • Patients with or suspected of having an inguinal hernia.
  • Patients with a history of open surgery within 12 weeks before obtaining consent (excluding appendicitis resection).
  • Patients with a history of surgical or endoscopic procedures related to cholecystectomy and papillotomy.
  • Patients with complications of malignancy.
  • Pregnant women, lactating women, women who may be currently pregnant, or patients who cannot consent to use contraception while participating in the study.
  • Patients with serious renal, liver, or cardiac disease.
  • Patients who are allergic to this study drug.
  • Patients who have previously taken Goufis tablets (elobixibat).
  • Patients with contraindications to rescue drugs (bisacodyl suppositories and prusenide tablets).
  • Patients who are participating in another clinical study or who were participating in another clinical study within 4 weeks before consent was obtained, excluding observational studies.
  • Patients who are judged by the principal investigator or sub-physician to be inappropriate for conducting this research.

Sites / Locations

  • Yokohama City UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Elobixibat

Placebo

Arm Description

AJG533 (elobixibat) 10 mg orally once a day before meals for 12 weeks

AJG533 placebo orally once a day before meals for 12 weeks

Outcomes

Primary Outcome Measures

Change in the number of complete spontaneous bowel movements at week 12
Change in the number of complete spontaneous bowel movements at week 12 of the treatment period from week 2 of the observation period. *Spontaneous defecation without residual sensation.

Secondary Outcome Measures

Change in the number of complete spontaneous bowel movements in each week of the treatment period.
Change in the number of complete spontaneous bowel movements in each week of the treatment period.
Change in the number of spontaneous bowel movements in each week of the treatment.
Change in the number of spontaneous bowel movements in each week of the treatment.
Proportion of responders** in the number of SBMs during each week.
Proportion of responders** in the number of spontaneous bowel movements (SBMs) during each week of the treatment period. **In this study, we will investigate the effect of the treatment on the number of SBMs of a subject who has at least one more SBM per week than in the second week of the observation period, and at least three times per week.
Proportion of responders** in the number of CSBMs during each week.
Proportion of responders** in the number of complete spontaneous a bowel movements (CSBMs) during each week of the treatment period. **In this study, we will investigate the effect of the treatment on the number of CSBMs of a subject who has at least one more CSBMs per week than in the second week of the observation period, and at least three times per week.
The rate of a responder in the number of CSBM during the treatment period.
Definition of Responder: Patients with 3 or more CSBM per week and 1 or more CSBM per week from baseline for 9 weeks out of the entire treatment period (12 weeks), including at least 3 weeks in the treatment period weeks 9 to 12.
Percent change in fecal hardness based on the Bristol Stool Quality Scale at each week.
Percent change in fecal hardness from week 2 of the observation period based on the Bristol Stool Quality Scale at each week of the treatment period. the minimum is 1 and maximum values, is 7.Higher scores mean a better outcome.
The percentage of change in the presence or absence of residual sensation at each week.
The percentage of change from week 2 of the observation period in the presence or absence of residual sensation at each week of the treatment period.
Percent change in the degree of twitching at each week.
Percent change from week 2 of the observation period in the degree of twitching at each week of the treatment period.
The percentage of change in the presence or absence of bowel movements at each week.
The percentage of change in the presence or absence of bowel movements at each week of the treatment period from week 2 of the observation period.
Change in Japanese Patient assessment of constipation quality of life score
Change in Japanese Patient assessment of constipation quality of life score at 4 and 12 weeks of the treatment period from the baseline (V2) of the study drug.the minimum is 0 and maximum values is 4.Lower scores mean a better outcome.
The changes in occupancy rate of intestinal microbiota.
At 4 weeks and 12 weeks of the treatment period, the changes in occupancy rate of intestinal microbiota in feces from before the start of the study drug (V2) are examined.
The change in absolute values rates in blood and fecal bile acids.
At 4 weeks and 12 weeks of the treatment period, the change in absolute values in blood and fecal bile acids from before the start of the study drug (V2) are examined.
The change in absolute values for organic acids.
At 4 weeks and 12 weeks of the treatment period, the change in absolute values for organic acids in feces from before the start of the study drug (V2) are examined.
The change in absolute values of amino acids in blood and feces.
At 4 weeks and 12 weeks of the treatment period, the change in absolute values of amino acids in blood and feces. from before the start of the study drug (V2) are examined.
The change in amount blood C4.
At 4 weeks and 12 weeks of the treatment period, the change in amount blood C4 from before the start of the study drug (V2) are examined.

Full Information

First Posted
February 28, 2021
Last Updated
January 3, 2023
Sponsor
Yokohama City University
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1. Study Identification

Unique Protocol Identification Number
NCT04784780
Brief Title
Long-term Elobixibat for Chronic Constipation
Acronym
TANK-27
Official Title
Long-term Efficacy and Safety of Elobixibat for Chronic Constipation: a Multicenter, Randomised, Double-blind, Placebo-controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
November 30, 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
In this double-blind comparative study, AJG533 (elobixibat) 10 mg or AJG533 placebo was orally administered once daily before meals for 12 weeks in patients with chronic constipation, and the primary endpoint was the change from Week 2 of the observation period in the number of complete spontaneous bowel movements (CSBM) at Week 12 of the treatment period. The primary endpoint was the change in the number of complete spontaneous bowel movements (CSBM) from Week 2 of the observation period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation
Keywords
Elobixibat, Chronic constipation, 12 week, Complete spontaneous bowel movement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Elobixibat
Arm Type
Experimental
Arm Description
AJG533 (elobixibat) 10 mg orally once a day before meals for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
AJG533 placebo orally once a day before meals for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Elobixibat 10mg
Other Intervention Name(s)
AJG533 10 mg
Intervention Description
Patients with chronic constipation are administered Elobixibat 10mg for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
AJG533 placebo
Intervention Description
Patients with chronic constipation are administered placebo for 12 weeks
Primary Outcome Measure Information:
Title
Change in the number of complete spontaneous bowel movements at week 12
Description
Change in the number of complete spontaneous bowel movements at week 12 of the treatment period from week 2 of the observation period. *Spontaneous defecation without residual sensation.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change in the number of complete spontaneous bowel movements in each week of the treatment period.
Description
Change in the number of complete spontaneous bowel movements in each week of the treatment period.
Time Frame
Each Week 1-11
Title
Change in the number of spontaneous bowel movements in each week of the treatment.
Description
Change in the number of spontaneous bowel movements in each week of the treatment.
Time Frame
Each Week 1-11
Title
Proportion of responders** in the number of SBMs during each week.
Description
Proportion of responders** in the number of spontaneous bowel movements (SBMs) during each week of the treatment period. **In this study, we will investigate the effect of the treatment on the number of SBMs of a subject who has at least one more SBM per week than in the second week of the observation period, and at least three times per week.
Time Frame
Each Week 1-11
Title
Proportion of responders** in the number of CSBMs during each week.
Description
Proportion of responders** in the number of complete spontaneous a bowel movements (CSBMs) during each week of the treatment period. **In this study, we will investigate the effect of the treatment on the number of CSBMs of a subject who has at least one more CSBMs per week than in the second week of the observation period, and at least three times per week.
Time Frame
Each Week 1-11
Title
The rate of a responder in the number of CSBM during the treatment period.
Description
Definition of Responder: Patients with 3 or more CSBM per week and 1 or more CSBM per week from baseline for 9 weeks out of the entire treatment period (12 weeks), including at least 3 weeks in the treatment period weeks 9 to 12.
Time Frame
Week 12
Title
Percent change in fecal hardness based on the Bristol Stool Quality Scale at each week.
Description
Percent change in fecal hardness from week 2 of the observation period based on the Bristol Stool Quality Scale at each week of the treatment period. the minimum is 1 and maximum values, is 7.Higher scores mean a better outcome.
Time Frame
Each Week 1-11
Title
The percentage of change in the presence or absence of residual sensation at each week.
Description
The percentage of change from week 2 of the observation period in the presence or absence of residual sensation at each week of the treatment period.
Time Frame
Each Week 1-11
Title
Percent change in the degree of twitching at each week.
Description
Percent change from week 2 of the observation period in the degree of twitching at each week of the treatment period.
Time Frame
Each Week 1-11
Title
The percentage of change in the presence or absence of bowel movements at each week.
Description
The percentage of change in the presence or absence of bowel movements at each week of the treatment period from week 2 of the observation period.
Time Frame
Each Week 1-11
Title
Change in Japanese Patient assessment of constipation quality of life score
Description
Change in Japanese Patient assessment of constipation quality of life score at 4 and 12 weeks of the treatment period from the baseline (V2) of the study drug.the minimum is 0 and maximum values is 4.Lower scores mean a better outcome.
Time Frame
Week 4, 12
Title
The changes in occupancy rate of intestinal microbiota.
Description
At 4 weeks and 12 weeks of the treatment period, the changes in occupancy rate of intestinal microbiota in feces from before the start of the study drug (V2) are examined.
Time Frame
Week 4, 12
Title
The change in absolute values rates in blood and fecal bile acids.
Description
At 4 weeks and 12 weeks of the treatment period, the change in absolute values in blood and fecal bile acids from before the start of the study drug (V2) are examined.
Time Frame
Week 4, 12
Title
The change in absolute values for organic acids.
Description
At 4 weeks and 12 weeks of the treatment period, the change in absolute values for organic acids in feces from before the start of the study drug (V2) are examined.
Time Frame
Week 4, 12
Title
The change in absolute values of amino acids in blood and feces.
Description
At 4 weeks and 12 weeks of the treatment period, the change in absolute values of amino acids in blood and feces. from before the start of the study drug (V2) are examined.
Time Frame
Week 4, 12
Title
The change in amount blood C4.
Description
At 4 weeks and 12 weeks of the treatment period, the change in amount blood C4 from before the start of the study drug (V2) are examined.
Time Frame
Week 4, 12
Other Pre-specified Outcome Measures:
Title
Incidence of adverse events.
Description
Incidence of adverse events.
Time Frame
Each Week 1-11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with chronic constipation by the "Rome IV" criteria for chronic constipation Age: 20 years old or older and up to 85 years old (at the time of obtaining consent) Gender: any gender outpatients Patients who can obtain written consent Patients who can record their defecation, etc. in the patient's diary At the time of allocation (dosing initiation criteria) Spontaneous bowel movements (SBM)* not more than 6 times during the 2-week observation period before the start of treatment Patients with no soft or watery stools (Bristol Stool Shape Scale 6 or 7) in spontaneous bowel movements during the 2-week observation period before the start of treatment. Patients who have not used concomitantly prohibited drugs or therapies during the observation period. Exclusion Criteria: Patients with organic constipation or patients with suspected organic constipation. Patients with or suspected of having functional ileus. Patients with or suspected of having an inguinal hernia. Patients with a history of open surgery within 12 weeks before obtaining consent (excluding appendicitis resection). Patients with a history of surgical or endoscopic procedures related to cholecystectomy and papillotomy. Patients with complications of malignancy. Pregnant women, lactating women, women who may be currently pregnant, or patients who cannot consent to use contraception while participating in the study. Patients with serious renal, liver, or cardiac disease. Patients who are allergic to this study drug. Patients who have previously taken Goufis tablets (elobixibat). Patients with contraindications to rescue drugs (bisacodyl suppositories and prusenide tablets). Patients who are participating in another clinical study or who were participating in another clinical study within 4 weeks before consent was obtained, excluding observational studies. Patients who are judged by the principal investigator or sub-physician to be inappropriate for conducting this research.
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
kessoku-tho@umin.ac.jp
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
29805116
Citation
Nakajima A, Seki M, Taniguchi S, Ohta A, Gillberg PG, Mattsson JP, Camilleri M. Safety and efficacy of elobixibat for chronic constipation: results from a randomised, double-blind, placebo-controlled, phase 3 trial and an open-label, single-arm, phase 3 trial. Lancet Gastroenterol Hepatol. 2018 Aug;3(8):537-547. doi: 10.1016/S2468-1253(18)30123-7. Epub 2018 May 25.
Results Reference
background
PubMed Identifier
35636802
Citation
Tanaka K, Kessoku T, Yamamoto A, Takahashi K, Kasai Y, Ozaki A, Iwaki M, Kobayashi T, Yoshihara T, Misawa N, Kato T, Arimoto J, Fuyuki A, Sakai E, Higurashi T, Chiba H, 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 multicentre, 12-week, randomised, double-blind, placebo-controlled, parallel-group, investigator-initiated trial to investigate the efficacy and safety of elobixibat for chronic constipation. BMJ Open. 2022 May 30;12(5):e060704. doi: 10.1136/bmjopen-2021-060704.
Results Reference
derived

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Long-term Elobixibat for Chronic Constipation

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