Verification of Stimulant Laxative Withdrawal Rate with Elovixibat

JRCT ID: jRCT1061210090

Registered date:26/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic functional constipation
• Date of first enrollment: 26/03/2022
• Target sample size: 42
• Study type: Observational

Outcome(s)

• Primary Outcome: Rate of withdrawal from regular use of stimulant laxatives
• Secondary Outcome: Changes in (complete) spontaneous defecation frequency, Bristol Stool Form Scale, VAS score (pain, fullness, heaviness, abdominal discomfort), constipation score (CSS), JPAC-QOL score, need for concomitant use of other drugs, type and ratio of concomitant drugs, score comparison for each concomitant drug, adverse events Correlation between stool and gas retention position on abdominal x-ray and response cases, median time from oral administration to first bowel movement

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

The following criteria will be considered for those who meet all of the following criteria
1Meet Rome IV criteria for chronic functional constipation
2No organic disease as a cause of constipation
3The patient is judged by our outpatient constipation clinic to require Elobixibat tablets as treatment for withdrawal from stimulant laxatives.
4Defecation is obtained by using stimulant laxatives.
5Not taking P-glycoprotein products
6Questionnaire items are audible.

• Exclude criteria: Diseases such as intestinal obstruction or enteritis that may be aggravated by continued use of Elobixibat tablets during the follow-up period.

Related Information

• Primary Sponsor: Kozuka Kazuhiro