Clinical trial NCT05165199: Elobixibat for Chronic Constipation Without Defecation Desire
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Constipation
Lead sponsor: Yokohama City University
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of change in loss of defecation desire
timeFrame: Week 4
Secondary outcomes:
measure: Presence of defecation desire
timeFrame: Week 4
measure: Satisfaction with defecation desire
timeFrame: Week 4
measure: Satisfaction of straining
timeFrame: Week 4
measure: Degree of straining
timeFrame: Week 4
measure: Presence of a sense of incomplete evacuation
timeFrame: Week 4
measure: Satisfaction with treatment
timeFrame: Week 4
measure: Spontaneous bowel movement (SBM) frequency
timeFrame: Week 4
measure: Complete Spontaneous Bowel Movement (CSBM) frequency
timeFrame: Week 4
measure: Stool hardness based on the Bristol Stool Form Scale
timeFrame: Week 4
measure: Constipation severity score
timeFrame: Week 4
measure: Japanese version of the Patient Assessment of Constipation Quality of Life
timeFrame: Week 4
measure: Change of bile acid cocentration
timeFrame: Week 4
measure: Change in defecation time.
timeFrame: Week 4
Other outcomes:
measure: Incidence rate of diseases
timeFrame: Week 0-4
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: 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.
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.