Elobixibat for Chronic Constipation Without Defecation Desire

NCT ID: NCT05165199

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Elobixibat

10mg Elobixibat administration for 4 weeks

Group Type: EXPERIMENTAL

Elobixibat 10mg

Intervention Type: DRUG

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

Interventions

Elobixibat 10mg

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yokohama City University

OTHER

Sponsor Role: lead

Responsible Party

Takaomi Kessoku

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Takaomi Kessoku, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

Yokohama City University

Locations

Yokohama City University

Yokohama, Kanagawa, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Takaomi Kessoku, M.D., PhD.

Role: CONTACT

takaomi0027@gmail.com

+81-45-787-2800 ext. 2640

Atsushi Nakajima, M.D., PhD.

Role: CONTACT

nakajima-tky@umin.ac.jp

+81-45-787-2800 ext. 2640

Facility Contacts

Takaomi Kessoku, MD., PhD.

Role: primary

kessoku-tho@umin.ac.jp

+81-45-787-2800 ext. 2640

References

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.

Reference Type: BACKGROUND

PMID: 32858571 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35812817 (View on PubMed)

Other Identifiers

21-008

Identifier Type: -

Identifier Source: org_study_id