Double-Blind, Randomized,Placebo-ControlledTrial ofDA-9701 in Parkinson's Disease:PASS-GIStudy
DC Field | Value | Language |
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dc.contributor.author | Choi, Ji-Hyun | - |
dc.contributor.author | Lee, Jee-Young | - |
dc.contributor.author | Cho, Jin Whan | - |
dc.contributor.author | Koh, Seong-Beom | - |
dc.contributor.author | Yang, Young Soon | - |
dc.contributor.author | Yoo, Dalla | - |
dc.contributor.author | Shin, Cheol-Min | - |
dc.contributor.author | Kim, Hee Tae | - |
dc.date.accessioned | 2021-12-08T19:42:23Z | - |
dc.date.available | 2021-12-08T19:42:23Z | - |
dc.date.created | 2021-08-30 | - |
dc.date.issued | 2020-11 | - |
dc.identifier.issn | 0885-3185 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/130399 | - |
dc.description.abstract | Objectives This study aimed to assess the efficacy of DA-9701 on gastrointestinal symptom-related quality of life in patients with Parkinson's disease on stable dopaminergic medications. Methods This multicenter, double-blind, placebo-controlled, phase 4 trial included a total of 144 patients with Parkinson's disease with gastrointestinal dysfunctions based on predefined criteria. Participants were randomized to take either DA-9701 or placebo for 4 weeks, and then both groups were administered DA-9701 for an additional 8 weeks while antiparkinsonian medications were unchanged. The primary outcome measure was gastrointestinal symptoms and related quality-of-life changes assessed on the Korean Nepean dyspepsia index after 4 and 12 weeks of therapy. We also evaluated the impact of DA-9701 therapy on parkinsonian motor symptoms at each time point. Results The gastrointestinal symptom-related quality-of-life score significantly improved in the DA-9701-treated group compared with the placebo-treated group after 4weeks (adjustedP= 0.012 by linear mixed effect model analysis). The overall gastrointestinal symptom and dyspepsia sum scores improved at 12 weeks after intervention in the DA-9701-first treated group (adjustedP= 0.002 and 0.014, respectively) and also in the placebo-first treated group (adjustedP= 0.019 and 0.039) compared with the baseline. Parkinsonian motor severity was not significantly affected by DA-9701 treatment in both groups at 4 and 12 weeks after intervention. There were no drug-related serious adverse events throughout the trial. Conclusions DA-9701 therapy improved gastrointestinal symptom-related quality of life, and 12 weeks of daily administration can relieve the overall severity of gastrointestinal symptoms in patients with Parkinson's disease without affecting motor symptoms. (Clinical trial identifier: NCT02775591.) (c) 2020 The Authors.Movement Disorderspublished by Wiley Periodicals LLC. on behalf of International Parkinson and Movement Disorder Society. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | WILEY | - |
dc.subject | BOTANICAL GASTROPROKINETIC AGENT | - |
dc.subject | PLACEBO-CONTROLLED TRIAL | - |
dc.subject | GASTRIC MOTOR FUNCTION | - |
dc.subject | PROKINETIC AGENT | - |
dc.subject | FUNCTIONAL DYSPEPSIA | - |
dc.subject | GASTROINTESTINAL SYMPTOMS | - |
dc.subject | MULTICENTER TRIAL | - |
dc.subject | DA-9701 | - |
dc.subject | ACCOMMODATION | - |
dc.subject | CONSTIPATION | - |
dc.title | Double-Blind, Randomized,Placebo-ControlledTrial ofDA-9701 in Parkinson's Disease:PASS-GIStudy | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Koh, Seong-Beom | - |
dc.identifier.doi | 10.1002/mds.28219 | - |
dc.identifier.scopusid | 2-s2.0-85089034753 | - |
dc.identifier.wosid | 000555965900001 | - |
dc.identifier.bibliographicCitation | MOVEMENT DISORDERS, v.35, no.11, pp.1966 - 1976 | - |
dc.relation.isPartOf | MOVEMENT DISORDERS | - |
dc.citation.title | MOVEMENT DISORDERS | - |
dc.citation.volume | 35 | - |
dc.citation.number | 11 | - |
dc.citation.startPage | 1966 | - |
dc.citation.endPage | 1976 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Neurosciences & Neurology | - |
dc.relation.journalWebOfScienceCategory | Clinical Neurology | - |
dc.subject.keywordPlus | BOTANICAL GASTROPROKINETIC AGENT | - |
dc.subject.keywordPlus | PLACEBO-CONTROLLED TRIAL | - |
dc.subject.keywordPlus | GASTRIC MOTOR FUNCTION | - |
dc.subject.keywordPlus | PROKINETIC AGENT | - |
dc.subject.keywordPlus | FUNCTIONAL DYSPEPSIA | - |
dc.subject.keywordPlus | GASTROINTESTINAL SYMPTOMS | - |
dc.subject.keywordPlus | MULTICENTER TRIAL | - |
dc.subject.keywordPlus | DA-9701 | - |
dc.subject.keywordPlus | ACCOMMODATION | - |
dc.subject.keywordPlus | CONSTIPATION | - |
dc.subject.keywordAuthor | DA-9701 | - |
dc.subject.keywordAuthor | double-blind randomized controlled trial | - |
dc.subject.keywordAuthor | gastrointestinal dysfunction | - |
dc.subject.keywordAuthor | Parkinson&apos | - |
dc.subject.keywordAuthor | s disease | - |
dc.subject.keywordAuthor | quality of life | - |
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