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Parkinson DiseasePhase 4PASS-GINCT02775591

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

A Phase 4 study testing DA-9701 in people with Parkinson Disease and Dyspepsia, run by Seoul National University Hospital at 5 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Parkinson Disease, Dyspepsia
What is being tested?
DA-9701
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
147 participants
Where
5 sitesSouth Korea
Study dates
Apr 2016to Dec 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

South Korea5 sites

  • Hanyang University Medical Center

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Boramae Hospital

    Seoul

  • Veterans Healthcare Service Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: Effect of Short-term Motilitone Therapy on Health-related Quality of Life in Parkinson's Disease Patients With Gastrointestinal Symptoms: a Multicenter, Double-blind Randomized, Placebo-controlled Trial

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.

Read the detailed description

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).

Being tested
DA-9701, DA-9701 placebo
Medical subject headings
Parkinson Disease, Dyspepsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DA-9701Drug

    Also called Motilitone

    DA-9701 30mg Tablet

  • DA-9701 placeboDrug

    Also called Motilitone placebo

    Placebo pill manufactured to mask DA-9701 30mg Tablet

Study groups in NCT02775591
Study groupRoleWhat they receive
Motilitone armExperimentalDA-9701 (Motilitone) 30mg 1T three times per day for 4+8 weeks
Receives: Drug: DA-9701
Placebo armPlacebo comparatorDA-9701 placebo 30mg 1T three times per day for 4 weeks, DA-9701 (Motilitone) 30mg 1T three times per day for 8 weeks
Receives: Drug: DA-9701; Drug: DA-9701 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the Nepean dyspepsia index-Korean version scores

    The Nepean dyspepsia index is a tool to measure gastrointestinal symptoms

    Measured: 4 weeks

Secondary outcomes (10)

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

    Mean bowel movements per day of recent 1 week will be asked using the bowel habit questionnaire.

    Measured: 4 weeks, 12 weeks

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

    Mean frequency of early satiety per day of recent 1 week will be asked using the bowel habit questionnaire. The frequency will be categorized as following: 0, no event; 1, once a day; 2, twice a day; 3, every meal.

    Measured: 4 weeks, 12 weeks

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

    Mean frequency of gastric fullness after a meal per day of recent 1 week will be asked using the bowel habit questionnaire. The frequency will be categorized as following: 0, no event; 1, once a day; 2, twice a day; 3, every meal.

    Measured: 4 weeks, 12 weeks

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

    Existence and severity of epigastric pain of recent 1 week will be asked using the bowel habit questionnaire. The severity will be categorized as following: 0, no event; 1, mild; 2, moderate; 3, severe; 4, very severe.

    Measured: 4 weeks, 12 weeks

  5. Change in the Bristol stool scale score

    This is a descriptive picture plate which patients can choose the type of their stool

    Measured: 4 weeks, 12 weeks

  6. Change in the Unified Parkinson's disease rating scale (UPDRS) scores

    This is a measure of the severity of Parkinson's disease

    Measured: 4 weeks, 12 weeks

  7. Change in the Parkinson's disease quality of life scale (PDQ-39) scores

    This is a measure of everyday quality of life affected by Parkinson's disease

    Measured: 4 weeks, 12 weeks

  8. Change in the Patient global improvement (PGI) scores

    This is a measure of patients perception of change in their gastrointestinal symptoms

    Measured: 4 weeks, 12 weeks

  9. Change in the Clinician global improvement (CGI) scores

    This is a measure of clinican's assessment of global clinical status of the patient

    Measured: 4 weeks, 12 weeks

  10. Change in the Nepean dyspepsia index-Korean version scores

    This is a measure of changes in gastrointestinal symptoms at the end of this trial

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionJun 2018
  4. Study completionDec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02775591
Sponsor's protocol ID
26-2016-11
Acronym
PASS-GI
Status last verified
Mar 2019
First submitted
9 May 2016
Last updated
28 Mar 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: DATA including IPD can be shared individually upon request by qualified investigators excluding patients' personal information

Publications

  • 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.

    PubMed 32761955

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing DA-9701 in people with Parkinson Disease and Dyspepsia, run by Seoul National University Hospital at 5 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Nepean dyspepsia index-Korean version scores (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02775591, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.

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PASS-GI Clinical Trial NCT02775591 | AzTrials