臨床研究等提出・公開システム

Date of registration	April. 06, 2026
Last modified on	Aug. 04, 2026
Trial ID	jRCT1061260004

Scientific Title	A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Elobixibat Hydrate in Preparing Patients with Chronic Constipation for Colonoscopy
Public Title	Evaluating the Efficacy of Elobixibat Hydrate in Preparing Patients with Chronic Constipation for Colonoscopy

Contact for Scientific Queries	Name	Oka Shiro
	Affiliation	Hiroshima University Hospital
	Address	Kasumi 1-2-3 Minami-ku, Hiroshima
	Telephone	+81-82-257-5190
	E-mail	oka4683@hiroshima-u.ac.jp
Contact for Public Queries	Name	Takasago Takeshi
	Affiliation	Hiroshima University Hospital
	Address	Kasumi 1-2-3 Minami-ku, Hiroshima
	Telephone	+81-82-257-5190
	E-mail	takasago@hiroshima-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 06, 2026
Actual date of first enrollment		May. 28, 2026
Target sample size		192
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients scheduled to undergo colonoscopy 2) Patients aged 18 years or older at the time of consent acquisition 3) Individuals for whom written informed consent for participation in this study can be obtained 4) Patients diagnosed by a physician with chronic constipation who meet two or more items of the ROMA-IV criteria for constipation and are in a chronic state
	Exclusion Criteria	1) Patients already taking Goofice 2) Patients with suspected gastrointestinal obstruction or intestinal obstruction 3) Patients with suspected intestinal perforation, gastric stasis, or toxic megacolon 4) Patients with inflammatory bowel disease 5) Patients who have undergone ileocecal resection or total colectomy 6) Women who are pregnant or may be pregnant, women who are breastfeeding, or women who wish to become pregnant 7) Patients with a history of hypersensitivity to Goofice, picosulfate sodium, or any component of Moviprep 8) Other patients deemed ineligible for enrollment in this study by the principal investigator or sub-investigator
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		chronic constipation
Intervention(s)		The study group will take Goofice 10 mg/day starting 3 days prior to colonoscopy. The control group will not take Goofice. Both groups will take picosulfate sodium the night before. Subsequently, on the day of colonoscopy, both groups will take Moviprep. The examination and various assessments will be performed on that day, concluding the study evaluation period.
Primary Outcome(s)		Total volume of Moviprep and water consumed until completion of bowel preparation
Secondary Outcome(s)		Quality of bowel preparation Evaluation of bowel movements during the 3 days prior to the procedure and on the morning of the procedure Time required for bowel preparation and assessment of acceptability of Moviprep Evaluation of adverse events during the study period

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Hiroshima University Certified Review Board
Address	Kasumi 1-2-3 Minami-ku, Hiroshima, Hiroshima
Telephone	+81-82-257-1551
E-Mail	iryo-sinsa@office.hiroshima-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 20, 2026

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Aug. 04, 2026	(this page)	Changes
1	April. 06, 2026	Detail

List of change history