Parkinson's disease, chronic constipation Parkinson's syndrome,chronic constipation,Symptomatic constipation
Conditions
Interventions
Take 10mg of Elobixibat or placebo once a day before meal. After the 2-week screening period, the study drug will be started on the day of enrollment.
Sponsors
Hatano Taku
Mochida Pharmaceutical Co., Ltd.
EA Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with Parkinson's disease in stages 1 to 4 on the Hoehn & Yahr scale 2) Patients with two or more of the following symptoms related to spontaneous bowel movement from at least 6 months before Informed Consent i)Fewer than 3 spontaneous bowel movements per week ii)Straining during more than 25% of defecations iii)Lumpy or hard stools more than 25% of defecations iv)Sensation of incomplete evacuation more than 25% of defecations 3)Patients aged >=20 years at the time of Informed Consent 4)Outpatient 5)Patients who can provide written Informed Consent
Exclusion criteria
Exclusion criteria: 1)Patients who have or are suspected to have organic constipation 2)Patients who have or are suspected to have dyschezia 3)Patients who are unable to use the rescue medication (Bisacodyl suppositories 10 mg) 4)Female patients who are pregnant, breastfeeding, or hope to raise children 5)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) or serious heart disease 6)Patients with malignant tumors 7)Patients with a history of hypersensitivity to Elobixibat 8)Patients who are taking bile acid preparations ( ursodeoxycholic acid, chenodeoxycholic acid), aluminum-containing preparations (sucralfatehydr ate, aldioxa, etc.), cholestyramine, colestimide or midazolam 9)Patients whose score of MMSE is 26 or less 10)Patients who were considered as ineligible by the investigator for safety or poor protocol compliance 11)Patients who used the rescue medication (Bisacodyl suppositories 10 mg) at least five times during the 2-week screening period 12)Patients who used the rescue medication less than 72 hours after bowel movement during the 2-week screening period 13)Patients with mushy stool or watery stools (BSFS type 6 or 7) in spontaneous bowel movement during the 2-week screening period 14)Patients who used prohibited medications/therapies during the 2-week screening period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of weekly frequency* of spontaneous bowel movement between screening period and treatment period week 4 *Frequency of bowel movement without suppositories, enema or disimpaction during each 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| -Changes in the frequency and transition of spontaneous bowel movement from screening period -Changes and transitions in complete spontaneous bowel movement* from screening period to treatment period week 4 -Changes in Bristol Stool Form Scale from screening period to treatment period week 4 -Usage of the rescue medication -JPAC-QOL -MDS-UPDRS -PDQ-39 -EQ-5D -Usage of dopamine antagonists -Subgroup analysis on the basis of background factors and dose of study drug *Spontaneous bowel movement without sensation of incomplete evacuation | — |
Contacts
Public ContactTaku Hatano
Juntendo University Hospital
Outcome results
None listed