Elobixibat for Chronic Constipation Without Defecation Desire

NCT05165199 | Unknown Phase 4 DMC

• 1 other identifier: 21-008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Constipation

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 4

Secondary Outcomes (13)

• Presence of defecation desire

  Week 4

• Satisfaction with defecation desire

  Week 4

• Satisfaction of straining

  Week 4

• Degree of straining

  Week 4

• Presence of a sense of incomplete evacuation

  Week 4

Other Outcomes (1)

• Incidence rate of diseases

  Week 0-4

Study Arms (1)

Elobixibat

EXPERIMENTAL

10mg Elobixibat administration for 4 weeks

Drug: Elobixibat 10mg

Interventions

Elobixibat 10mg DRUG

Patients of chronic constipation with loss of defecation desire are administered Elobixibat 10mg for 4 weeks

Elobixibat

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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".

You may not qualify if:

• 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

Sponsors & Collaborators

• Yokohama City University: lead

Study Sites (1)

Yokohama City University

Yokohama, Kanagawa, 236-0004, Japan

RECRUITING

Related Publications (2)

• 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.

  PMID: 32858571 BACKGROUND

• 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.

  PMID: 35812817 DERIVED

MeSH Terms

Interventions

elobixibat

Study Officials

• Takaomi Kessoku, M.D., PhD.

  Yokohama City University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Takaomi Kessoku, M.D., PhD.

CONTACT

+81-45-787-2800; takaomi0027@gmail.com

Atsushi Nakajima, M.D., PhD.

CONTACT

+81-45-787-2800; nakajima-tky@umin.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2021
• First Posted: December 21, 2021
• Study Start: March 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)