Multicenter, Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study Investigating the Efficacy and Safety of Elobixibat in Patients with Parkinson's Disease Complicating Chronic Constipation. (CONST-PD)

Not provided0 sites100 target enrollmentStarted: December 23, 2020Last updated: January 24, 2024

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Enrollment: 100
Primary Endpoint: Comparison of weekly frequency of spontaneous bowel movement between screening period and treatment period week 4

No summary available.

•<At the time of temporary registration>
•Patients with Parkinson's disease in stages 1 to 4 on the Hoehn & Yahr scale
•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
•Patients aged >=20 years at the time of Informed Consent
•Outpatient
•Patients who can provide written Informed Consent

•<At the time of temporary registration/registration>
•Patients who have or are suspected to have organic constipation
•Patients who have or are suspected to have dyschezia
•Patients who are unable to use the rescue medication (Bisacodyl suppositories 10 mg)
•Female patients who are pregnant, breastfeeding, or hope to raise children
•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
•Patients with malignant tumors
•Patients with a history of hypersensitivity to Elobixibat
•Patients who are taking bile acid preparations ( ursodeoxycholic acid, chenodeoxycholic acid), aluminum-containing preparations (sucralfatehydr ate, aldioxa, etc.), cholestyramine, colestimide or midazolam
•Patients whose score of MMSE is 26 or less
•Patients who were considered as ineligible by the investigator for safety or poor protocol compliance
•<At the time of registration>
•Patients who used the rescue medication (Bisacodyl suppositories 10 mg) at least five times during the 2-week screening period
•Patients who used the rescue medication less than 72 hours after bowel movement during the 2-week screening period
•Patients with mushy stool or watery stools (BSFS type 6 or 7) in spontaneous bowel movement during the 2-week screening period
•Patients who used prohibited medications/therapies during the 2-week screening period

Comparison of weekly frequency of spontaneous bowel movement between screening period and treatment period week 4

Time Frame: treatment period week 4

*Frequency of bowel movement without suppositories, enema or disimpaction during each 7 days

Changes in the frequency and transition of spontaneous bowel movement(screening period)
Changes and transitions in complete spontaneous bowel movement(screening period to treatment period week 4)
Changes in Bristol Stool Form Scale(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

Sponsor

Not provided