Elobixibat for Chronic Constipation Without Defecation Desire (R-LODD)

A Multicenter, Single-group, Open-label, Before-and-after Study Confirming Recovery of Defecation Desire by Administration of Elobixibat in Patients With Chronic Constipation

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Constipation
• Intervention / Treatment: Drug: Elobixibat 10mg

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Atsushi Nakajima, M.D., PhD.; Phone Number: 2640 +81-45-787-2800; Email: nakajima-tky@umin.ac.jp
• Study Contact Backup: Name: Takaomi Kessoku, M.D., PhD.; Phone Number: 2640 +81-45-787-2800; Email: takaomi0027@gmail.com

Study Locations

• Japan
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 236-0004
      • Recruiting
      • Yokohama city university
      • Contact: Takaomi Kessoku, MD., PhD.; Phone Number: 2640 +81-45-787-2800; Email: kessoku-tho@umin.ac.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elobixibat; 10mg Elobixibat administration for 4 weeks	Drug: Elobixibat 10mg; Patients of chronic constipation with loss of defecation desire are administered Elobixibat 10mg for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of defecation desire	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 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
Satisfaction with defecation desire	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).	Week 4
Satisfaction of straining	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period(patient questionnaire).	Week 4
Degree of straining	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period(patient questionnaire).	Week 4
Presence of a sense of incomplete evacuation	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).	Week 4
Satisfaction with treatment	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).	Week 4
Spontaneous bowel movement (SBM) frequency	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient daily).	Week 4
Complete Spontaneous Bowel Movement (CSBM) frequency	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient daily).	Week 4
Stool hardness based on the Bristol Stool Form Scale	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).	Week 4
Constipation severity score	Comparison of the Constipation severity score at Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).	Week 4
Japanese version of the Patient Assessment of Constipation Quality of Life	Comparison of the Japanese version of the Patient Assessment of Constipation Quality of Life questionrair at Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).	Week 4
Change of bile acid cocentration	Comparison of the bile acid concentration at Week 4 of the treatment period with Week 2 of the observation period (serum and feces).	Week 4
Change in defecation time.	Changes in the time from taking elobixibat to defecation each week during the treatment period	Week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of diseases	Safety assessment	Week 0-4

Collaborators and Investigators

• Sponsor: Yokohama City University
• Investigators: Principal Investigator: Takaomi Kessoku, M.D., PhD., Yokohama city university

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: December 4, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 21-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No