Clinical trial NCT04784780: Long-term Elobixibat for Chronic Constipation
Official title: Long-term Efficacy and Safety of Elobixibat for Chronic Constipation: a Multicenter, Randomised, Double-blind, Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Constipation
Keywords: Elobixibat
Chronic constipation
12 week
Complete spontaneous bowel movement
Lead sponsor: Yokohama City University
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in the number of complete spontaneous bowel movements at week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change in the number of complete spontaneous bowel movements in each week of the treatment period.
timeFrame: Each Week 1-11
measure: Change in the number of spontaneous bowel movements in each week of the treatment.
timeFrame: Each Week 1-11
measure: Proportion of responders** in the number of SBMs during each week.
timeFrame: Each Week 1-11
measure: Proportion of responders** in the number of CSBMs during each week.
timeFrame: Each Week 1-11
measure: The rate of a responder in the number of CSBM during the treatment period.
timeFrame: Week 12
measure: Percent change in fecal hardness based on the Bristol Stool Quality Scale at each week.
timeFrame: Each Week 1-11
measure: The percentage of change in the presence or absence of residual sensation at each week.
timeFrame: Each Week 1-11
measure: Percent change in the degree of twitching at each week.
timeFrame: Each Week 1-11
measure: The percentage of change in the presence or absence of bowel movements at each week.
timeFrame: Each Week 1-11
measure: Change in Japanese Patient assessment of constipation quality of life score
timeFrame: Week 4, 12
measure: The changes in occupancy rate of intestinal microbiota.
timeFrame: Week 4, 12
measure: The change in absolute values rates in blood and fecal bile acids.
timeFrame: Week 4, 12
measure: The change in absolute values for organic acids.
timeFrame: Week 4, 12
measure: The change in absolute values of amino acids in blood and feces.
timeFrame: Week 4, 12
measure: The change in amount blood C4.
timeFrame: Week 4, 12
Other outcomes:
measure: Incidence of adverse events.
timeFrame: Each Week 1-11
Locations:
city: Yokohama
country: Japan
facility: Yokohama City University
state: Kanagawa
Study officials:
affiliation: Yokohama City University
name: Takaomi Kessoku, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.