Efficacy and safety of Elobixibat in preparation for colonoscopy patients

Phase 2

• Conditions: Patients undergoing colonoscopy

• Registration Number: JPRN-jRCTs031200209
• Lead Sponsor: Ashikari Keiichi

Brief Summary

Significant data have been reported from other centers, and we believe that continuation of this study is of low clinical value. The study will be terminated with zero patients enrolled.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-20
• Study Completion: 2022-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

(1) Patients capable of taking oral bowel cleansers who are undergoing colonoscopy.
(2) Patients over 20 years of age at the time of obtaining consent.
(3) Patients who take an oral bowel cleanser in the hospital.
(4) Patients with written consent to participate in this study.
(5) Patients who are able to walk independently and respond to questionnaires and other surveys.

Exclusion Criteria

(1) Patients with advanced colorectal cancer, extramural compression due to intra-abdominal tumors, Crohn's disease, ischemic colitis, and bowel obstruction.
(2) Patients with previous colorectal resection.
(3) Patients with extremely poor general health, NYHA cardiac function classifications III and IV with severe cardiac disease and renal disease with eGFR<30.
(4) Patients with significant electrolyte abnormalities with a serum Na concentration of less than 135 mEq/L, 148 mEq/L or greater, or a serum K concentration of less than 3.5 mEq/L or greater than 5.0 mEq/L.
(5) Patients with a history of hypersensitivity to the components of Goofice tablets (elobixibat).
(6) Patients who do not undergo total colorectal observation.
(7) Patients who participated in a drug or other clinical trial at the same time as the study or within 30 days prior to inclusion in the study.
(8) Patients taking Goofice tablets (elobixibat).
(9) Patients who are pregnant, lactating, or who may be pregnant.
(10) Other patients who are deemed unsuitable for inclusion in the subject by the physician.
(11) Patients on the Bristol Stool Form Scale 1 or 2.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bowel Cleanliness (BBPS)

Secondary Outcome Measures

Name	Time	Method
Insertion time and total inspection time<br>Tolerability and satisfaction using patient questionnaires<br>Any side effects (e.g., abdominal pain, nausea, bloating, etc.) from pretreatment<br>The time it takes to take a polyethylene glycol (PEG) formulation<br>Pretreatment non-completion rate<br>Adenoma detection rate (ADR)