UMIN-CTR 臨床試験登録情報の閲覧

BACK TOP
UMIN-CTR ホーム 用語の説明(簡易版) 用語の説明(詳細版)--準備中 FAQ

利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000043848
受付番号 R000050047
科学的試験名
一般公開日(本登録希望日) 2021/04/29
最終更新日 2021/04/29

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
The safety and effectiveness of mirabegron in Parkinson's disease patients with overactive bladder
一般向け試験名略称/Acronym
SEMPDOAB
科学的試験名/Scientific Title
The safety and effectiveness of mirabegron in Parkinson's disease patients with overactive bladder : A randomized controlled trial
科学的試験名略称/Scientific Title:Acronym
SEMPDOABRCT
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
Overactive bladder
疾患区分1/Classification by specialty
泌尿器科学/Urology
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
To assess the safety and effectiveness of mirabegron in patients with PD complaining of overactive bladder(OAB)
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 検証的/Confirmatory
試験の性質2/Trial characteristics_2 その他/Others
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
The primary outcomes of our study were the change from baseline in OAB symptom score, overactive bladder questionnaire short form score
副次アウトカム評価項目/Key secondary outcomes


基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding 二重盲検/Double blind -all involved are blinded
コントロール/Control プラセボ・シャム対照/Placebo
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration 施設を考慮していない/Institution is not considered as adjustment factor.
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 知る必要がない/No need to know

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
医薬品/Medicine
介入1/Interventions/Control_1
Treatment group receiving daily mirabegron 50mg for 12 weeks
介入2/Interventions/Control_2
Placebo group
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
40 歳/years-old より上/<
年齢(上限)/Age-upper limit
70 歳/years-old 未満/>
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
Inclusion criteria for this study were patients with a clinical diagnosis of PD according to UK Brain Bank Criteria which demands bradykinesia and one additional symptom (rigidity, resting tremor, or postural instability). The diagnostic criteria were tested by a movement disorders specialist in the 12 months before receiving mirabegron therapy. Patients should be aged between 40 and 70 years, have a stable dose of antiparkinsonian drugs 8 weeks before study entry, stage 1 to 3 on modified Hoehn and Yahr scale. Patients received mirabegron 50 mg once daily, have post-void residue less than 100ml on an ultrasound of the bladder performed before study entry, patients were taking only levodopa or dopamine agonist at stable doses before entering the study, used at least for 12 weeks mirabegron 50mg and accomplish one visit of followup at the end of therapy.
除外基準/Key exclusion criteria
Exclusion criteria were patients with secondary parkinsonism syndromes, patients with polyuria with a daily urine volume more than 3000 mL, patients receiving monoamine oxidase B inhibitors and catecholOmethyltransferase (COMT) inhibitors for PD, patients operated previously by deep brain stimulation, patients taking anticholinergic medications for (overactive bladder) OAB symptoms, history of benign prostatic hypertrophy (males only), patients with stress urinary incontinence,
history of severe uncontrolled hypertensive patients (defined as systolic blood pressure more oe equal than 180 mm Hg and/or diastolic blood pressure more or equal than 110 mm Hg) or bladder outflow obstruction or gastrointestinal obstructive disorders, history of narrow-angle glaucoma, history of pelvic radiation. More exclusion criteria included: current treatment with digoxin, ketoconazole, drugs classified as CYP2D6 substrate, patients with a history of QT interval prolongation or taking drugs that prolong the QT interval, patients with severe renal impairment (GFR less than30ml per min) or moderate to severe hepatic impairment (ChildPugh B&C).
目標参加者数/Target sample size 110

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Mohamad
ミドルネーム
Abou Chakra
所属組織/Organization
Al Zahraa Hospital
所属部署/Division name
Urology
郵便番号/Zip code 1108
住所/Address
Beirut, Lebanon
電話/TEL 0096171613732
Email/Email mohamedabouchakra@hotmail.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Mohamad
ミドルネーム
Moussa
組織名/Organization
Al Zahraa Hospital
部署名/Division name
Urology
郵便番号/Zip code 1108
住所/Address
Beirut, Lebanon
電話/TEL 00961964412
試験のホームページURL/Homepage URL
Email/Email mohamadamoussa@hotmail.com

実施責任組織/Sponsor
機関名/Institute その他 Al Zahraa Hospital
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 None
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
Al zahraa Hospital
住所/Address
Beirut, Lebanon
電話/Tel 009611851040ext3364
Email/Email uroprog@gmail

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2021 04 29

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled 95
主な結果/Results
There was a significant improvement in the primary outcome and secondary outcome measures in the treatment group compared to placebo group. Adverse events included constipation and xerostomia, which resolved after treatment was discontinued. Adverse events were mild .
主な結果入力日/Results date posted
2021 04 06
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2016 12 10
倫理委員会による承認日/Date of IRB
2016 12 16
登録・組入れ開始(予定)日/Anticipated trial start date
2017 01 10
フォロー終了(予定)日/Last follow-up date
2020 11 25
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2021 04 06
最終更新日/Last modified on
2021 04 29


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050047
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050047

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


UMIN臨床試験登録システムのご使用に関するお問い合わせは、こちらのお問い合わせフォーム からお願いいたします。それ以外のお問い合わせは、 こちら よりお願い致します。