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

NCT02775591 | Completed Phase 4

• 1 other identifier: 26-2016-11
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Parkinson Disease; Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Change in the Nepean dyspepsia index-Korean version scores

  The Nepean dyspepsia index is a tool to measure gastrointestinal symptoms

  4 weeks

Secondary Outcomes (10)

• Change in bowel movements per day assessed by a bowel habit questionnaire.

  4 weeks, 12 weeks

• Change in frequency of early satiety per day assessed by a bowel habit questionnaire.

  4 weeks, 12 weeks

• Change in frequency of gastric fullness after a meal per day assessed by a bowel habit questionnaire.

  4 weeks, 12 weeks

• Change in severity of epigastric pain assessed by a bowel habit questionnaire.

  4 weeks, 12 weeks

• Change in the Bristol stool scale score

  4 weeks, 12 weeks

Study Arms (2)

Motilitone arm

EXPERIMENTAL

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

Drug: DA-9701

Placebo arm

PLACEBO COMPARATOR

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

Drug: DA-9701; Drug: DA-9701 placebo

Interventions

DA-9701 DRUG

DA-9701 30mg Tablet

Also known as: Motilitone

Motilitone arm; Placebo arm

DA-9701 placebo DRUG

Placebo pill manufactured to mask DA-9701 30mg Tablet

Also known as: Motilitone placebo

Placebo arm

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Samsung Medical Center: collaborator
• Korea University Guro Hospital: collaborator
• Hanyang University: collaborator
• Seoul Veterans Hospital: collaborator
• SMG-SNU Boramae Medical Center: collaborator

Study Sites (5)

Hanyang University Medical Center

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Boramae Hospital

Seoul, South Korea

Location

Veterans Healthcare Service Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Choi JH, Lee JY, Cho JW, Koh SB, Yang YS, Yoo D, Shin CM, Kim HT. Double-Blind, Randomized, Placebo-Controlled Trial of DA-9701 in Parkinson's Disease: PASS-GI Study. Mov Disord. 2020 Nov;35(11):1966-1976. doi: 10.1002/mds.28219. Epub 2020 Aug 6.

  PMID: 32761955 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Dyspepsia

Interventions

DA-9701

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jee-Young Lee, MD, PhD

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 17, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: The information will be judged by the principal investigator upon individual request.
• Access Criteria: The information will be judged by the principal investigator upon individual request.

Locations

KR (5)