A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder
2012年12月10日 更新者：Pfizer
A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Vulnerable Elderly Patients With Overactive Bladder.
This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).
調査の概要
研究の種類
介入
入学 (実際)
566
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35233
- Pfizer Investigational Site
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Birmingham、Alabama、アメリカ、35294
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Montgomery、Alabama、アメリカ、36117
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Arizona
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Green Valley、Arizona、アメリカ、85614
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Mesa、Arizona、アメリカ、85206-1734
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Phoenix、Arizona、アメリカ、85032
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Tucson、Arizona、アメリカ、85712
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Tuscon、Arizona、アメリカ、85710
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Arkansas
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Little Rock、Arkansas、アメリカ、72223
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Little Rock、Arkansas、アメリカ、72204
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California
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Costa Mesa、California、アメリカ、92626
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Fairfield、California、アメリカ、94534
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Glendora、California、アメリカ、91741
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La Mesa、California、アメリカ、91942
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Long Beach、California、アメリカ、90806
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Mission Viejo、California、アメリカ、92691
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Murrieta、California、アメリカ、92562
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Norwalk、California、アメリカ、90650
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Paramount、California、アメリカ、90723
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Rancho Santa Margarita、California、アメリカ、92688
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San Bernardino、California、アメリカ、92404
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San Diego、California、アメリカ、92108
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Santa Ana、California、アメリカ、92705
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Temecula、California、アメリカ、92591
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Vacaville、California、アメリカ、95688
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Colorado
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Aurora、Colorado、アメリカ、80012
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Colorado Springs、Colorado、アメリカ、80907
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Colorado Springs、Colorado、アメリカ、80909
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Denver、Colorado、アメリカ、80220
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Denver、Colorado、アメリカ、80211
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Englewood、Colorado、アメリカ、80113
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Englewood、Colorado、アメリカ、80110
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Longmont、Colorado、アメリカ、80501
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Parker、Colorado、アメリカ、80134
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Connecticut
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Groton、Connecticut、アメリカ、06340
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Milford、Connecticut、アメリカ、06460
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New London、Connecticut、アメリカ、06320
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Florida
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Bonita Springs、Florida、アメリカ、34134
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Boynton Beach、Florida、アメリカ、33472
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Brooksville、Florida、アメリカ、34601
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Clearwater、Florida、アメリカ、33756
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Daytona Beach、Florida、アメリカ、32114
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DeLand、Florida、アメリカ、32720
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Ft. Lauderdale、Florida、アメリカ、33316
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Lake Worth、Florida、アメリカ、33461
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Melbourne、Florida、アメリカ、32901
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Naples、Florida、アメリカ、34102
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New Port Richey、Florida、アメリカ、34655
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New Port Richey、Florida、アメリカ、34652
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Ocala、Florida、アメリカ、34471
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Plant City、Florida、アメリカ、33563
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Sarasota、Florida、アメリカ、34237
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St. Petersburg、Florida、アメリカ、33710
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Trinity、Florida、アメリカ、34655
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Wellington、Florida、アメリカ、33449
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Winter Haven、Florida、アメリカ、33880
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Georgia
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Atlanta、Georgia、アメリカ、30067
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Macon、Georgia、アメリカ、31217
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Illinois
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Springfield、Illinois、アメリカ、62702
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Springfield、Illinois、アメリカ、62703
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Indiana
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Newburgh、Indiana、アメリカ、47630
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Kansas
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Arkansas City、Kansas、アメリカ、67005
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Kansas City、Kansas、アメリカ、66160-7390
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Wichita、Kansas、アメリカ、67207
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Wichita、Kansas、アメリカ、67205
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Kentucky
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Lexington、Kentucky、アメリカ、40504
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Lexington、Kentucky、アメリカ、40503
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Louisiana
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Shreveport、Louisiana、アメリカ、71106
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Maryland
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Baltimore、Maryland、アメリカ、21211
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Glen Burnie、Maryland、アメリカ、21061
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Towson、Maryland、アメリカ、21204
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Massachusetts
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Springfield、Massachusetts、アメリカ、01103
- Pfizer Investigational Site
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Michigan
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Grand Rapids、Michigan、アメリカ、49503
- Pfizer Investigational Site
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Kalamazoo、Michigan、アメリカ、49009
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Minnesota
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Edina、Minnesota、アメリカ、55435
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Mississippi
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Picayune、Mississippi、アメリカ、39466
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Southaven、Mississippi、アメリカ、38671
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Missouri
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St. Louis、Missouri、アメリカ、63117
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Nebraska
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Lincoln、Nebraska、アメリカ、68516
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Omaha、Nebraska、アメリカ、68114
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Nevada
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Las Vegas、Nevada、アメリカ、89119
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New Jersey
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Moorestown、New Jersey、アメリカ、08057
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Sewell、New Jersey、アメリカ、08080
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New York
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Albany、New York、アメリカ、12208
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Brooklyn、New York、アメリカ、11215
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Staten Island、New York、アメリカ、10304
- Pfizer Investigational Site
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Williamsville、New York、アメリカ、14221
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North Carolina
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Cary、North Carolina、アメリカ、27518
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Cary、North Carolina、アメリカ、27511
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Raleigh、North Carolina、アメリカ、27612
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Ohio
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Willoughby Hills、Ohio、アメリカ、44094
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Oklahoma
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Bethany、Oklahoma、アメリカ、73008
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Norman、Oklahoma、アメリカ、73069
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Oklahoma City、Oklahoma、アメリカ、73112
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Oklahoma City、Oklahoma、アメリカ、73109
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Oregon
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Portland、Oregon、アメリカ、97205
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Pennsylvania
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Altoona、Pennsylvania、アメリカ、16602
- Pfizer Investigational Site
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Erie、Pennsylvania、アメリカ、16507
- Pfizer Investigational Site
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Pittsburgh、Pennsylvania、アメリカ、15243
- Pfizer Investigational Site
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Rhode Island
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East Providence、Rhode Island、アメリカ、02914
- Pfizer Investigational Site
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East Providence、Rhode Island、アメリカ、02915
- Pfizer Investigational Site
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- Pfizer Investigational Site
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Columbia、South Carolina、アメリカ、29201
- Pfizer Investigational Site
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Myrtle Beach、South Carolina、アメリカ、29572
- Pfizer Investigational Site
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Tennessee
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Bristol、Tennessee、アメリカ、37620
- Pfizer Investigational Site
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Chattanooga、Tennessee、アメリカ、37404
- Pfizer Investigational Site
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Jackson、Tennessee、アメリカ、38305
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Memphis、Tennessee、アメリカ、38119
- Pfizer Investigational Site
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Texas
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Austin、Texas、アメリカ、78745
- Pfizer Investigational Site
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Austin、Texas、アメリカ、78757
- Pfizer Investigational Site
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Corpus Christi、Texas、アメリカ、78414
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Houston、Texas、アメリカ、77074
- Pfizer Investigational Site
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Houston、Texas、アメリカ、77062
- Pfizer Investigational Site
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Leander、Texas、アメリカ、78641
- Pfizer Investigational Site
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Longview、Texas、アメリカ、75605
- Pfizer Investigational Site
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Longview、Texas、アメリカ、75601
- Pfizer Investigational Site
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San Antonio、Texas、アメリカ、78229
- Pfizer Investigational Site
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San Antonio、Texas、アメリカ、78216
- Pfizer Investigational Site
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Temple、Texas、アメリカ、76508
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Utah
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Murray、Utah、アメリカ、84107
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Salt Lake City、Utah、アメリカ、84103
- Pfizer Investigational Site
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West Jordan、Utah、アメリカ、84088
- Pfizer Investigational Site
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Virginia
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Richmond、Virginia、アメリカ、23229
- Pfizer Investigational Site
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Washington
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Burien、Washington、アメリカ、98166
- Pfizer Investigational Site
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Spokane、Washington、アメリカ、99216
- Pfizer Investigational Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
65年歳以上 (高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- male or female subjects 65 years of age or older
- OAB symptoms for at least 3 months
- score 3 or greater on Vulnerable Elderly Survey (VES-13)
- adequate mobility for independent toileting
- mean number of at least 2 UUI episodes per 24 hours
- mean urinary frequency of 8 or more micturitions per 24 hours
- able to independently complete the bladder diaries
Exclusion Criteria:
- PVR urinary volume greater than 200 ml
- MMSE score less than 20
- greater than 15 UUI episodes per 24 hours
- creatinine clearance less than 30 ml/min
- an average resting heart rate of greater than or equal to 90 beats per minute
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：プラセボ
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Placebo sham 4 mg and 8 mg
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実験的：フェソテロジン
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Fesoterodine 4 mg and 8 mg
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
時間枠：Baseline
|
UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary.
USS total range 1 to 5: 1.
No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
|
Baseline
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Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
時間枠：Baseline, Week 12
|
UUI episodes were defined as those with the USS rating of 5 in the diary.
USS total range 1 to 5: 1.
No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
|
Baseline, Week 12
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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過活動膀胱アンケート (OAB-q) 症状 迷惑スコア
時間枠：ベースライン
|
OAB-q: 参加者が選択した膀胱の症状にどれだけ悩まされているかを評価する自己管理型の 33 項目のアンケート。
リッカート尺度 1 (最も症状が気になる) から 6 (最も症状が気になる) で参加者が評価した各項目。
質問 1 ～ 8 のスコアの合計として導出される症状の煩わしさスコア。可能な限り低い未加工スコア: 8;最高スコア: 48.
スコアを 0 から 100 のスケール [(実際の未処理スコアの合計 - 未処理スコアの可能な最小値)/範囲]*100 に変換することに基づいて分析されたデータ。
より高いスコア値は、より大きな症状の煩わしさを示しています。
|
ベースライン
|
|
健康関連の生活の質 (HRQL) ドメインと過活動膀胱アンケート (OAB-q) の合計スコア
時間枠：ベースライン
|
OAB-q: 自己管理式、33 項目のアンケートで、参加者が選択した膀胱の症状にどれだけ悩まされているかを評価します。
各項目は、リッカート スケール 1 (最も症状が気になる) から 6 (最も症状が気になる) で評価されます。
質問 9 ～ 33 は HRQL を構成し、懸念、対処、睡眠、および社会的機能の領域を含みます。
スコアの合計として導出された HRQL ドメインおよび総生スコア。
変換されたスコア範囲 0 から 100 (合計 HRQL またはドメイン) = [(可能な最高の生スコア - 実際の合計生スコア)/生スコア範囲]*100。
変換されたスコアが高いほど、HRQL が優れていることを示します。
|
ベースライン
|
|
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4
時間枠：Baseline, Week 4
|
UUI episodes were defined as those with the USS rating of 5 in the diary.
USS total range 1 to 5: 1.
No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
|
Baseline, Week 4
|
|
Percent Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12
時間枠：Baseline, Week 4, 12
|
Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).
|
Baseline, Week 4, 12
|
|
Mean Number of Micturitions Per 24 Hours
時間枠：Baseline
|
Micturitions include episodes of voluntary micturition and episodes of UUI.
UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline.
USS rating 5: Unable to hold; leak urine.
|
Baseline
|
|
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12
時間枠：Baseline, Week 4, 12
|
Micturitions include episodes of voluntary micturition and episodes of UUI.
UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline.
USS rating 5: Unable to hold; leak urine.
|
Baseline, Week 4, 12
|
|
Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12
時間枠：Baseline, Week 4, 12
|
Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).
|
Baseline, Week 4, 12
|
|
Mean Number of Micturition-related Urgency Episodes Per 24 Hours
時間枠：Baseline
|
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit.
USS total range 1 to 5: 1.
No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
|
Baseline
|
|
Change From Baseline in Mean Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
時間枠：Baseline, Week 4, 12
|
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit.
USS total range 1 to 5: 1.
No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
|
Baseline, Week 4, 12
|
|
Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
時間枠：Baseline, Week 4, 12
|
Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).
|
Baseline, Week 4, 12
|
|
Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours
時間枠：Baseline
|
Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day.
Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.
|
Baseline
|
|
Change From Baseline in Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
時間枠：Baseline, Week 4, 12
|
Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day.
Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.
|
Baseline, Week 4, 12
|
|
Percent Change From Baseline in Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
時間枠：Baseline, Week 4, 12
|
Percent change of nocturnal micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).
|
Baseline, Week 4, 12
|
|
Frequency-Urgency Sum Rating Per 24 Hours
時間枠：Baseline
|
Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day.
Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit.
USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.
|
Baseline
|
|
Change From Baseline in Frequency-Urgency Sum Rating Per 24 Hours at Week 4 and 12
時間枠：Baseline, Week 4, 12
|
Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day.
Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit.
USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.
Numerical decrease indicates improvement.
|
Baseline, Week 4, 12
|
|
Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12
時間枠：Baseline, Week 4, 12
|
Protective Undergarments included pads, protective padding, protective underwear (pull up), and briefs (diaper).
The mean number of undergarments changed per 24 hours was calculated as the total number of undergarments changed divided by the total number of diary days collected at that visit.
Change from baseline values were reported at week 4 for subsets of population with baseline values less than or equal to (=<) 3.5 and more than (>) 3.5 undergarments/day and at Week 12 for subsets of population with baseline values =< 2.5 and > 2.5 undergarments/day.
|
Baseline, Week 4, 12
|
|
Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12
時間枠：Screening, Week 4, 12
|
PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems.
The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems.
Deterioration=score difference is greater than 0; no change=score difference is 0; minor improvement=score difference is -1; major difference=score difference is less than or equal to -2.
|
Screening, Week 4, 12
|
|
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12
時間枠：Baseline, Week 4, 12
|
OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms.
Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother).
Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48.
Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100.
Higher scores values indicative of greater symptom bother.
|
Baseline, Week 4, 12
|
|
Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12
時間枠：Baseline, Week 4, 12
|
OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms.
Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother).
Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function.
HRQL domain and total raw score derived as sum of scores.
Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100.
Higher transformed scores indicative of better HRQL.
|
Baseline, Week 4, 12
|
|
Overactive Bladder Satisfaction Questionnaire (OAB-S) Total Score on Satisfaction With OAB Control
時間枠：Week 12
|
OAB-S: a validated self-administered instrument that evaluates OAB medication expectations, daily life with AB, and satisfaction with OAB medication and includes 3 stand-alone items that assess overall expectation, satisfaction, and willingness to continue treatment.
Satisfaction coded on scale of 1 to 5: (1=very satisfied to 5=very dissatisfied).
Coding reversed algorithmically and results transformed: total score range 0 to100.
Higher final response value associated with better satisfaction.
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Week 12
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Percentage of Participants With Overactive Bladder Satisfaction Questionnaire (OAB-S) Global Medication Satisfaction Question Response
時間枠：Week 12
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Participant's response to question, "overall, how satisfied are you with your OAB medication?" was obtained on a 5 point scale, 1- very satisfied, 2- somewhat satisfied, 3- neither dissatisfied nor satisfied, 4- somewhat dissatisfied and 5- very dissatisfied.
Response values 1 and 2 were combined into "satisfied", and 4 and 5 were combined into "dissatisfied".
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Week 12
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Mini Mental State Examination (MMSE)
時間枠：Screening
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MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions.
Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state.
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Screening
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Change From Screening in Mini Mental State Examination (MMSE) Score at Week 12
時間枠：Screening, Week 12
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MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions.
Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state.
Change: mean score at Week X minus mean score at baseline
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Screening, Week 12
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Change From Baseline in Post Void Residual (PVR) Volume at Week 4 and 12
時間枠：Baseline, Week 4, 12
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PVR volume is defined as volume of urine remaining in the bladder immediately after urination.
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Baseline, Week 4, 12
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協力者と研究者
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スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年9月1日
一次修了 (実際)
2011年9月1日
研究の完了 (実際)
2011年9月1日
試験登録日
最初に提出
2009年6月24日
QC基準を満たした最初の提出物
2009年6月24日
最初の投稿 (見積もり)
2009年6月25日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年1月17日
QC基準を満たした最後の更新が送信されました
2012年12月10日
最終確認日
2012年12月1日
詳しくは
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