Exploratory examination about the gene background to affect the stool frequency change at the Linacrotide and Elobxibat hydrate administration.

JRCT ID: jRCT1041200023

Registered date:26/06/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic constipation
• Date of first enrollment: 26/06/2020
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Linacrotide and Elobxibat hydrate administration.

Outcome(s)

• Primary Outcome: A correlation between genetic polymorphism and stool frequency change at Linacrotide and Elobixibat hydrate administration.

Key inclusion & exclusion criteria

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

Include criteria

1)A disease name: Chronic constipation
2)Form: Functional constipation
3)Age: 20 years or older
4)Sex: Regardless of men and women
5) An index of the overall status: Performance Status (ECOG) is 0 or 1
6) Written patient compliance: After the informed consent that is enough on participating to this study, an agreement by the free will of the patients is obtained.

Exclude criteria

1)The patients who take irritant cathartic day after day(However, the trial entry is possible if the patients doing one-off use internal use can establish the interval for stage Washout of 2W).
2)The patients with a history of the remedy in Lubiprostone, Linaclotide, Elobixbat hydrate.
3)The patients with the serious hepatic disorder ( AST(GOT) or ALT (GPT) 100IU/L or more).
4)The patients with serious renal disease.
5)The patients with the serious systemic disease with cancer, diabetes, heart disorder, and the like.
6)The patients with the pregnant or pregnant possibility.
7)The patients who participated in other clinical trials. (clinical study) within three months before study drug beginning of dosage.
8)The patients whom an anticholinergic drug, an antipsychotic drug, anti-Parkinson medicine, opioids are given, and chemical constipation is suspected in.
9)The patients who judged a study responsibility physician or a study allotment physician to be inadequate as study patients.

Related Information

• Primary Sponsor: Nakamura Masakatsu
• Secondary Sponsor: Tomiyasu Arisawa