Overview

Effect of Short-term Motilitone Therapy on Health-related Quality of Life in PD Patients With Gastrointestinal Symptoms

Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether DA-9701(Motilitone) is effective and safe for the treatment on health-related quality of life in Parkinson's disease (PD) patients with gastrointestinal symptoms.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seoul National University Hospital
Collaborators:
Hanyang University
Korea University Guro Hospital
Samsung Medical Center
Seoul Veterans Hospital
SMG-SNU Boramae Medical Center
Criteria
Inclusion Criteria:

- Subjects were enrolled voluntarily and understood the contents of this clinical trial.

- Male or female Parkinson disease (PD) patients between 50 and 80 years

- Subjects who had not received prokinetics (itopride, mosapride, Corydalis tuber,
levosulpiride, domperidone, etc.) at least 2 months prior to baseline visit

- Subjects complained at least one symptom of the following that suggests abnormal bowel
functions: anorexia, nausea, abdominal distension, dyspepsia, early satiety,
dysphagia, foreign body sensation associated with a meal, symptoms of gastroesophageal
reflux, constipation, and defecation problem.

Exclusion Criteria:

- History of a gastrointestinal operation

- Subjects with active gastrointestinal diseases under treatment of gastroenterology
within 1 month

- Existence of clinically significant cognitive decline or K-Minimental Status Exam
score 20 or less

- Subjects had depression or other psychiatric disorders treated with medications such
as antidepressants or antipsychotics; mood tranquilizers, benzodiazepines, and sleep
pills were permitted with fixed dose during a period of the clinical trial

- Subjects with severe active comorbidities which could interfere the quality of life of
the patient

- Subjects with medical conditions which make difficult to be enrolled to the trial
judged by clinicians

- Subjects with hypersensitivity or adverse event related to DA-9701 (Motilitone)

- Prior participation to other clinical trials within 3 months