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)

未提供0 个研究点目标入组 100 人开始时间: 2020年12月23日最近更新: 2024年1月24日

适应症

试验速览

阶段: 不适用
状态: 已完成
入组人数: 100
主要终点: Comparison of weekly frequency of spontaneous bowel movement between screening period and treatment period week 4

暂无简介。

•<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

时间窗: 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

发起方

未提供