Chronic constipation
Conditions
Interventions
Patients with chronic constipation group Elobixibat 10 mg will be administered about 30 minutes before breakfast once daily for 7 days.
Healthy volunteer group Healthy volunteers will not receive elob
Sponsors
Hasunuma Tomoko
EA Pharma Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with chronic constipation (1)Patients aged >=20 years at the time of informed consent (2)Patients whose mean Spontaneous Bowel Movement was =20 years at the time of informed consent (2)Volunteers who have bowel movements almost every day (3)Volunteers who have no disease requiring routine treatment (4)Volunteers capable of giving written informed consent
Exclusion criteria
Exclusion criteria: Patients with chronic constipation (1)Patients with, or suspected to have, organic constipation, symptomatic constipation or drug-induced constipation (2)Patients with a medical history of gastrointestinal obstruction (3)Patients with abdominal hernia (4)Patients with a surgical history of small or large intestine other than simple appendectomy (5)Patients with a medical history of surgical or endoscopic intervention related to cholecystectomy and papillotomy (6)Patients who are proven to be positive for HBs antigen, anti-HCV antibody, serological reaction of syphilis, or anti- HIV-1, 2 antibodies (7)Patients with current medical history of serious dysfunction related to the kidney (creatinine>=2.00 mg/dL)or the liver (total bilirubin >=3.0 mg/dL or AST or ALT >=100 U/L) (8)Patients with a history of serious drug-induced allergy (9)Patients with a past or current medical history of drug poisoning or alcohol poisoning (10)Pregnant women, lactating women, women with pregnancy suspected (11)Patients who used the rescue medication within 72 hours after bowel movement during the 2-week screening period (12)Patients with soft stool or watery stool (Bristol Stool Form Scale type 6 or 7) in Spontaneous Bowel Movement during the 2-week screening period and during the 1-week baseline period (13)Patients who used the rescue medication more than four times during the 2-week screening period (14)Patients who used prohibited medications/therapies from the beginning of 2-week screening period to the day of hospitalization (15)Patients who used the rescue medication during the 1-week baseline period (16)Patients who were considered as ineligible by the investigator for any other reasons Healthy volunteers (1)Volunteers with a medical history of gastrointestinal obstruction (2)Volunteers with abdominal hernia (3)Volunteers with a surgical history of small or large intestine other than simple appendectomy (4)Volunteers who are proven to be positive for HBs antigen, anti-HCV antibody, serological reaction of syphilis, or anti- HIV-1, 2 antibodies (5)Volunteers with a history of serious drug-induced allergy (6)Volunteers with a past or current medical history of drug poisoning or alcohol poisoning (7)Volunteers women, lactating women, women with pregnancy suspected (8)Volunteers whose mean Spontaneous Bowel Movement was =<3 times/week during the 1-week screening period (9)Volunteers who used prohibited medications/therapies from the beginning of 1-week screening period to the day of hospitalization (10)Volunteers who were considered as ineligible by the investigator for any other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the amount of bile acids in the stool after the completion of treatment with elobixibat from the baseline in patients with chronic constipation | — |
Secondary
| Measure | Time frame |
|---|---|
| -Comparison of the amount of bile acids and bile acid fractions in the stool, bile acid concentrations and bile acid fractions in the blood, C4 and FGF19 concentrations in the blood during the baseline period in patients with chronic constipation with that in the stool in healthy adult volunteers. -Comparison of bile acid fractions in the stool, bile acid concentrations and bile acid fractions in the blood, C4 and FGF19 concentrations in the blood during the baseline period in patients with chronic constipation with or without elobixibat administration. -Relationship of bile acid concentrations and bile acid fractions in the stool, bile acid concentrations and bile acid fractions in the blood, C4 and FGF19 concentrations in the blood with pharmacological evaluation index (stool form, stool weight, water content in the stool, frequency of bowel movements, time to Spontaneous Bowel Movement, straining, and defecation desire, etc.) -Stool form, stool weight, water content in the stool, frequency of bowel movements, sensation of incomplete evacuation, Time from administration to Spontaneous Bowel Movement, straining, and defecation desire, etc. -Comparison of bile acid concentrations in each defecation (spot stool) with those in 48-hour stool collected. | — |
Contacts
Public ContactKuniaki Fukushima
Kitasato University Kitasato Institute Hospital
Outcome results
None listed