臨床研究等提出・公開システム

Efficacy and safety of Elobixibat as a preparation for colonoscopy: a single-center, open-label, randomized controlled exploratory trial (none)

Efficacy and safety of Elobixibat in preparation for colonoscopy patients

0

None

None

None

None

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.

Mar. 31, 2022

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs031200209

Ashikari Keiichi

Yokohama City University Hospital

3-9, Fukuura, Kanazawa-ku, Yokohama, Japan

ashikari@yokohama-cu.ac.jp

Ashikari Keiichi

Yokohama City University Hospital

3-9, Fukuura, Kanazawa-ku, Yokohama, Japan

+81-45-787-2800

ashikari@yokohama-cu.ac.jp

Complete

Nov. 20, 2020

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

screening

(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.

(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.

Both

Patients undergoing colonoscopy

Goofice tablets (10 mg per dose, taken orally before sleep) only on the day before the colonoscopy

Goofice

Bowel Cleanliness (BBPS)

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

+81-45-370-7627

Nov. 10, 2020

none