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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Gastrointestinal (GI) symptoms are frequently complained by PD patients. To improve their symptoms, prokinetics are often used in clinics. However, some prokinetics are dopamine receptor antagonist which can aggravate motor symptoms of PD patients or develop tardive dyskinesia when it affects dopamine receptors of the brain.

DA-9701 (Motilitone) is recently developed herbal medication which has both 5-HT4 agonism and D2 antagonism. Furthermore, it does not cross the blood brain barrier that can be safely used in PD patients. Hypothetically it has a potential to be a good choice for the treatment of GI symptoms of PD patients. However, there has been no study that evaluates its efficacy and safety by randomized clinical trials in PD patients.

This study will evaluate the efficacy and safety of DA-9701 in the double-blind placebo-controlled phase 1 (4 weeks), and the long-term safety of DA-9701 in the open-label phase 2 (8 weeks after phase 1).

Conditions

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Parkinson Disease Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Motilitone arm

DA-9701 (Motilitone) 30mg 1T three times per day for 4+8 weeks

Group Type EXPERIMENTAL

DA-9701

Intervention Type DRUG

DA-9701 30mg Tablet

Placebo arm

DA-9701 placebo 30mg 1T three times per day for 4 weeks, DA-9701 (Motilitone) 30mg 1T three times per day for 8 weeks

Group Type PLACEBO_COMPARATOR

DA-9701

Intervention Type DRUG

DA-9701 30mg Tablet

DA-9701 placebo

Intervention Type DRUG

Placebo pill manufactured to mask DA-9701 30mg Tablet

Interventions

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DA-9701

DA-9701 30mg Tablet

Intervention Type DRUG

DA-9701 placebo

Placebo pill manufactured to mask DA-9701 30mg Tablet

Intervention Type DRUG

Other Intervention Names

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Motilitone Motilitone placebo

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No