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Efficacy and safety of Elobixibat in preparation for colonoscopy patients

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031200209
Enrollment
200
Registered
2020-11-20
Start date
2020-11-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing colonoscopy

Interventions

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

Sponsors

Ashikari Keiichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Bowel Cleanliness (BBPS)

Secondary

MeasureTime frame
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)

Contacts

Public ContactKeiichi Ashikari

Yokohama City University Hospital

ashikari@yokohama-cu.ac.jp+81-45-787-2800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026