Efficacy and safety of Elobixibat in preparation for colonoscopy patients

JRCT ID: jRCTs031200209

Registered date:20/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients undergoing colonoscopy
• Date of first enrollment: 20/11/2020
• Target sample size: 200
• Study type: Interventional
• Intervention(s): Goofice tablets (10 mg per dose, taken orally before sleep) only on the day before the colonoscopy

Outcome(s)

• Primary Outcome: Bowel Cleanliness (BBPS)

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Ashikari Keiichi