이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Clinical Trial to Evaluate the Efficacy and Safety of Fesoterodine in Comparison to Tolterodine for Overactive Bladder (OAB)

2015년 3월 4일 업데이트: Pfizer

12-Week, Randomized, Double-Blind, Double-Dummy,Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Comparison To Tolterodine ER In Patients With Overactive Bladder (OAB)

To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

1712

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 그리스
      • Rio, Patras, 그리스, 26500
        • Pfizer Investigational Site
      • Thessaloniki, 그리스, 56403
        • Pfizer Investigational Site
    • Attiki
      • Athens, Attiki, 그리스, 10552
        • Pfizer Investigational Site
    • Ipiros
      • Ioannina, Ipiros, 그리스, 45001
        • Pfizer Investigational Site
  • 남아프리카
      • Cape Town, 남아프리카, 8001
        • Pfizer Investigational Site
      • Pretoria, 남아프리카, 0083
        • Pfizer Investigational Site
    • Free State
      • Bloemfontein, Free State, 남아프리카, 9300
        • Pfizer Investigational Site
    • Gauteng
      • Vosloorus, Gauteng, 남아프리카, 1475
        • Pfizer Investigational Site
    • Gauteng Province
      • Parktown, Gauteng Province, 남아프리카, 2193
        • Pfizer Investigational Site
    • Kwa Zulu Natal
      • Durban, Kwa Zulu Natal, 남아프리카, 4001
        • Pfizer Investigational Site
      • Pietermaritzburg, Kwa Zulu Natal, 남아프리카, 3201
        • Pfizer Investigational Site
  • 노르웨이
      • Bergen, 노르웨이, 5005
        • Pfizer Investigational Site
      • Hamar, 노르웨이, 2317
        • Pfizer Investigational Site
      • Lysaker, 노르웨이, 1366
        • Pfizer Investigational Site
      • Oslo, 노르웨이, NO-0257
        • Pfizer Investigational Site
      • Oslo, 노르웨이, 0264
        • Pfizer Investigational Site
      • Sandnes, 노르웨이, 4313
        • Pfizer Investigational Site
  • 대만
      • Hualien, 대만, 970
        • Pfizer Investigational Site
      • Taichung City, 대만, 40705
        • Pfizer Investigational Site
      • Taipei, 대만, 100
        • Pfizer Investigational Site
      • Taipei, 대만
        • Pfizer Investigational Site
    • Kaohsiung
      • Niao-Sung Hsiang, Kaohsiung, 대만, 833
        • Pfizer Investigational Site
  • 대한민국
      • Daegu, 대한민국, 705-718
        • Pfizer Investigational Site
      • Seoul, 대한민국, 120-752
        • Pfizer Investigational Site
      • Seoul, 대한민국, 136-705
        • Pfizer Investigational Site
      • Seoul, 대한민국, 137-040
        • Pfizer Investigational Site
      • Seoul, 대한민국, 100-380
        • Pfizer Investigational Site
    • Korea
      • Seoul, Korea, 대한민국, 110-744
        • Pfizer Investigational Site
  • 덴마크
      • Aalborg, 덴마크, 9100
        • Pfizer Investigational Site
      • Aarhus N, 덴마크, 8200
        • Pfizer Investigational Site
      • Glostrup, 덴마크, 2600
        • Pfizer Investigational Site
      • Herlev, 덴마크, 2730
        • Pfizer Investigational Site
      • Kolding, 덴마크, 6000
        • Pfizer Investigational Site
      • Nykoebing Falster, 덴마크, 4800
        • Pfizer Investigational Site
      • Roskilde, 덴마크, 4000
        • Pfizer Investigational Site
  • 독일
      • Ahaus, 독일, 41683
        • Pfizer Investigational Site
      • Alzey, 독일, 55232
        • Pfizer Investigational Site
      • Berlin, 독일, 10787
        • Pfizer Investigational Site
      • Berlin, 독일, 13125
        • Pfizer Investigational Site
      • Berlin, 독일, 13347
        • Pfizer Investigational Site
      • Karlsruhe, 독일, 76199
        • Pfizer Investigational Site
      • Krumbach, 독일, 86381
        • Pfizer Investigational Site
      • Leipzig, 독일, 04109
        • Pfizer Investigational Site
      • Leipzig, 독일, 04105
        • Pfizer Investigational Site
      • Marburg, 독일, 35039
        • Pfizer Investigational Site
      • Muelheim a.d. Ruhr, 독일, 45468
        • Pfizer Investigational Site
      • Muenchen, 독일, 81241
        • Pfizer Investigational Site
      • Muenchen, 독일, 81925
        • Pfizer Investigational Site
      • Rosenheim, 독일, 83022
        • Pfizer Investigational Site
  • 러시아 연방
      • Moscow, 러시아 연방, 101000
        • Pfizer Investigational Site
      • Moscow, 러시아 연방, 115516
        • Pfizer Investigational Site
      • Moscow, 러시아 연방, 117815
        • Pfizer Investigational Site
      • Rostov-on-Don, 러시아 연방, 344022
        • Pfizer Investigational Site
    • Russia
      • Moscow, Russia, 러시아 연방, 105425
        • Pfizer Investigational Site
      • St. Petersburg, Russia, 러시아 연방
        • Pfizer Investigational Site
  • 루마니아
      • Arad, 루마니아, 310175
        • Pfizer Investigational Site
      • Bucuresti, 루마니아, 041345
        • Pfizer Investigational Site
      • Bucuresti, 루마니아, 050653
        • Pfizer Investigational Site
      • Sibiu, 루마니아, 550245
        • Pfizer Investigational Site
      • Timisoara, 루마니아, 300736
        • Pfizer Investigational Site
  • 말레이시아
      • Kuala Lumpur, 말레이시아, 59100
        • Pfizer Investigational Site
    • Selangor
      • Batu Caves, Selangor, 말레이시아, 68100
        • Pfizer Investigational Site
  • 미국
    • Alabama
      • Homewood, Alabama, 미국, 35209
        • Pfizer Investigational Site
      • Huntsville, Alabama, 미국, 35801
        • Pfizer Investigational Site
      • Mobile, Alabama, 미국, 36608
        • Pfizer Investigational Site
    • California
      • Carmichael, California, 미국, 95608
        • Pfizer Investigational Site
      • Orangevale, California, 미국, 95662
        • Pfizer Investigational Site
      • San Diego, California, 미국, 92103-6204
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, 미국, 80012
        • Pfizer Investigational Site
    • Connecticut
      • Waterbury, Connecticut, 미국, 06708
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, 미국, 33186
        • Pfizer Investigational Site
      • Wellington, Florida, 미국, 33414
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, 미국, 30342
        • Pfizer Investigational Site
    • Idaho
      • Coeur D Alene, Idaho, 미국, 83814
        • Pfizer Investigational Site
      • Sandpoint, Idaho, 미국, 83864
        • Pfizer Investigational Site
    • Illinois
      • Aurora, Illinois, 미국, 60504
        • Pfizer Investigational Site
    • Iowa
      • West Des Moines, Iowa, 미국, 50266
        • Pfizer Investigational Site
    • Kansas
      • Newton, Kansas, 미국, 67114
        • Pfizer Investigational Site
    • Louisiana
      • Shrevport, Louisiana, 미국, 71106
        • Pfizer Investigational Site
    • Massachusetts
      • Watertown, Massachusetts, 미국, 02472
        • Pfizer Investigational Site
    • Minnesota
      • Chaska, Minnesota, 미국, 55318
        • Pfizer Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, 미국, 08648
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87109
        • Pfizer Investigational Site
    • New York
      • Garden City, New York, 미국, 11530
        • Pfizer Investigational Site
      • Mineola, New York, 미국, 11501
        • Pfizer Investigational Site
    • North Carolina
      • Burlington, North Carolina, 미국, 27215
        • Pfizer Investigational Site
      • Concord, North Carolina, 미국, 28025
        • Pfizer Investigational Site
      • Huntersville, North Carolina, 미국, 28078
        • Pfizer Investigational Site
    • Ohio
      • Dayton, Ohio, 미국, 45439
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, 미국, 18106
        • Pfizer Investigational Site
      • Allentown, Pennsylvania, 미국, 18103
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, 미국, 15212
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, 미국, 15213-3180
        • Pfizer Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, 미국, 02914
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, 미국, 29425
        • Pfizer Investigational Site
      • Columbia, South Carolina, 미국, 29201
        • Pfizer Investigational Site
    • Tennessee
      • Kingsport, Tennessee, 미국, 37660
        • Pfizer Investigational Site
      • Milan, Tennessee, 미국, 38358
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, 미국, 77024
        • Pfizer Investigational Site
    • Utah
      • Provo, Utah, 미국, 84604
        • Pfizer Investigational Site
    • Virginia
      • Chesapeake, Virginia, 미국, 23320
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, 미국, 98104
        • Pfizer Investigational Site
    • Wisconsin
      • Menomonee Falls, Wisconsin, 미국, 53051
        • Pfizer Investigational Site
  • 벨기에
      • Antwerpen, 벨기에, 2020
        • Pfizer Investigational Site
      • Bruxelles, 벨기에, 1070
        • Pfizer Investigational Site
      • Kortrijk, 벨기에, 8500
        • Pfizer Investigational Site
      • Tessenderlo, 벨기에, 3980
        • Pfizer Investigational Site
  • 브라질
    • BA
      • Salvador, BA, 브라질, 40420-000
        • Pfizer Investigational Site
    • RJ
      • Rio de Janeiro, RJ, 브라질, CEP 20551-030
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, 브라질, 90020-090
        • Pfizer Investigational Site
      • Porto Alegre, RS, 브라질, 90470-340
        • Pfizer Investigational Site
    • SP
      • Campinas, SP, 브라질, 13084-882
        • Pfizer Investigational Site
      • São Paulo, SP, 브라질, 04262-000
        • Pfizer Investigational Site
      • São Paulo, SP, 브라질, 04039-901
        • Pfizer Investigational Site
  • 스웨덴
      • Huskvarna, 스웨덴, 561 36
        • Pfizer Investigational Site
      • Lulea, 스웨덴, 97180
        • Pfizer Investigational Site
      • Malmo, 스웨덴, 205 02
        • Pfizer Investigational Site
      • Skovde, 스웨덴, 541 30
        • Pfizer Investigational Site
      • Stockholm, 스웨덴
        • Pfizer Investigational Site
  • 스위스
      • Frauenfeld, 스위스, CH-8500
        • Pfizer Investigational Site
      • Luzern 16, 스위스, CH-6000
        • Pfizer Investigational Site
  • 스페인
      • Madrid, 스페인, 28046
        • Pfizer Investigational Site
      • Valencia, 스페인, 46010
        • Pfizer Investigational Site
    • Madrid
      • Getafe, Madrid, 스페인, 28905
        • Pfizer Investigational Site
    • Vizcaya
      • Bilbao, Vizcaya, 스페인, 48013
        • Pfizer Investigational Site
  • 싱가포르
      • Singapore, 싱가포르, 119074
        • Pfizer Investigational Site
      • Singapore, 싱가포르, 229899
        • Pfizer Investigational Site
  • 우크라이나
      • Chernivtsi, 우크라이나, 58002
        • Pfizer Investigational Site
      • Kharkiv, 우크라이나, 61037
        • Pfizer Investigational Site
      • Kyiv, 우크라이나, 04053
        • Pfizer Investigational Site
      • Odessa, 우크라이나, 65000
        • Pfizer Investigational Site
      • Zaporizhzhia, 우크라이나, 69000
        • Pfizer Investigational Site
  • 이탈리아
      • Latina, 이탈리아, 04100
        • Pfizer Investigational Site
      • Padova, 이탈리아, 35128
        • Pfizer Investigational Site
      • Siena, 이탈리아, 53100
        • Pfizer Investigational Site
  • 인도
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, 인도, 500 001
        • Pfizer Investigational Site
      • Hyderabad, Andhra Pradesh, 인도, 500 082
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, 인도, 560 034
        • Pfizer Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, 인도, 302 004
        • Pfizer Investigational Site
    • Tamil Nadu
      • Vellore, Tamil Nadu, 인도, 632 004
        • Pfizer Investigational Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, 인도, 226003
        • Pfizer Investigational Site
  • 체코 공화국
      • Hradec Kralove, 체코 공화국, 500 02
        • Pfizer Investigational Site
      • Jablonec nad Nisou, 체코 공화국, 466 60
        • Pfizer Investigational Site
      • Jindrichuv Hradec, 체코 공화국, 377 38
        • Pfizer Investigational Site
      • Ostrava, 체코 공화국, 708 52
        • Pfizer Investigational Site
      • Praha 8, 체코 공화국, 180 00
        • Pfizer Investigational Site
  • 칠레
      • Puerto Montt, 칠레, 5480000
        • Pfizer Investigational Site
      • Santiago, 칠레
        • Pfizer Investigational Site
    • VI Región
      • Rancagua, VI Región, 칠레, 2820945
        • Pfizer Investigational Site
  • 캐나다
    • Alberta
      • Calgary, Alberta, 캐나다, T2V 4R6
        • Pfizer Investigational Site
      • Edmonton, Alberta, 캐나다, T5H 3V9
        • Pfizer Investigational Site
    • British Columbia
      • Victoria, British Columbia, 캐나다, V8V 3N1
        • Pfizer Investigational Site
    • New Brunswick
      • Saint John, New Brunswick, 캐나다, E2L 3J8
        • Pfizer Investigational Site
    • Ontario
      • Kitchener, Ontario, 캐나다, N2N 2B9
        • Pfizer Investigational Site
      • Toronto, Ontario, 캐나다, M4N 3M5
        • Pfizer Investigational Site
      • Toronto, Ontario, 캐나다, M6A 3B5
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, 캐나다, H2X 1N8
        • Pfizer Investigational Site
      • Montreal, Quebec, 캐나다, H3S 1Z1
        • Pfizer Investigational Site
      • Montréal, Quebec, 캐나다, H2X 3J4
        • Pfizer Investigational Site
      • Sherbrooke, Quebec, 캐나다, J1H 5N4
        • Pfizer Investigational Site
  • 코스타리카
      • Alajuela, 코스타리카
        • Pfizer Investigational Site
      • Cartago, 코스타리카
        • Pfizer Investigational Site
      • San Jose, 코스타리카
        • Pfizer Investigational Site
  • 콜롬비아
    • Cundinamarca
      • Bogota, Cundinamarca, 콜롬비아
        • Pfizer Investigational Site
      • Bogota, Cundinamarca, 콜롬비아
        • Pfizer Investigational Site
  • 페루
      • Lima, 페루, L27
        • Pfizer Investigational Site
    • Lima
      • Surco, Lima, 페루, L33
        • Pfizer Investigational Site
  • 폴란드
      • Bialystok, 폴란드, 15-950
        • Pfizer Investigational Site
      • Bydgoszcz, 폴란드, 85-168
        • Pfizer Investigational Site
      • Lodz, 폴란드, 91-463
        • Pfizer Investigational Site
      • Szczecin, 폴란드, 70-11
        • Pfizer Investigational Site
      • Warszawa, 폴란드, 02-507
        • Pfizer Investigational Site
  • 헝가리
      • Debrecen, 헝가리, 4026
        • Pfizer Investigational Site
      • Nyiregyhaza, 헝가리, 4400
        • Pfizer Investigational Site
      • Szeged, 헝가리, 6725
        • Pfizer Investigational Site
      • Szentes, 헝가리, 6600
        • Pfizer Investigational Site
  • 홍콩
      • Hong Kong, 홍콩
        • Pfizer Investigational Site
      • Shatin, 홍콩
        • Pfizer Investigational Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Adult overactive bladder (OAB) patients who present with OAB symptoms, including urinary frequency >= 8 per day and urgency urinary incontinence >=1 per day

Exclusion Criteria:

  • Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
  • Patients with significant hepatic and renal disease or other significant unstable diseases.
  • OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 페소테로딘
태블릿
의약품: fesoterodine fumarate
4 mg once daily (OD) for 1 week followed by a forced dose-escalation to 8 mg once daily (OD) for 11 weeks
위약 비교기: Placebo
Tablets and capsules
의약품: placebo
once daily (OD)for 12 weeks
활성 비교기: Tolterodine
Capsules
의약품: tolterodine tartrate
4 mg once daily (OD) for 12 weeks

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).
기간: Baseline, Week 12
UUI per 24 hours: total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change: mean at observation minus mean at baseline.
Baseline, Week 12

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.
기간: Baseline, Week 1, Week 4
UUI episodes per 24 hours calculated as total number of micturitions with Urinary Sensation Scale (USS) of 5 divided by total number of diary days collected at visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Baseline, Week 1, Week 4
Percent Change From Baseline of UUI Episodes Per 24 Hours.
기간: Baseline, Week 1, Week 4, Week 12
UUI episodes per 24 hours calculated as total number of micturitions with USS of 5 in diary. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as UUI episodes per 24 hours at observation divided by baseline number of UUI episodes per 24 hours, multiplied by 100.
Baseline, Week 1, Week 4, Week 12
Change From Baseline in Mean Voided Volume Per Micturition.
기간: Baseline, Week 1, Week 4, Week 12
Mean voided volume calculated as sum of voided volume divided by the total number of micturition episodes with a recorded voided volume greater than 0 in the 3-day diary at that visit.
Baseline, Week 1, Week 4, Week 12
Change From Baseline in Mean Number of Micturitions Per 24 Hours.
기간: Baseline, Week 1, Week 4, Week 12
The mean number of micturitions was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change calculated as mean at observation minus mean at baseline.
Baseline, Week 1, Week 4, Week 12
Percent Change From Baseline of Micturitions Per 24 Hours.
기간: Baseline, Week 1, Week 4, Week 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 (ie, 100% *(Week 12 or 4 - baseline)/baseline).
Baseline, Week 1, Week 4, Week 12
Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours.
기간: Baseline, Week 1, Week 4, Week 12
Mean number of nocturnal micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.
Baseline, Week 1, Week 4, Week 12
Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours.
기간: Baseline, Week 1, Week 4, Week 12
Percent change of nocturnal 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 (ie, 100% *(Week 12 or 4 - baseline)/baseline). Nocturnal (Bedtime) was defined as the time the subject went to bed until he/she arose to start the next day.
Baseline, Week 1, Week 4, Week 12
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours.
기간: Baseline, Week 1, Week 4, Week 12
Mean number urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as sum of all micturitions divided by total number of diary days collected at visit. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Baseline, Week 1, Week 4, Week 12
Percent Change From Baseline of Urgency Episodes Per 24 Hours.
기간: Baseline, Week 1, Week 4, Week 12
Percent change of urgency episodes (USS rating >= to 3 in diary) per 24 hours calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100. USS: 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Baseline, Week 1, Week 4, Week 12
Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours.
기간: Baseline, Week 1, Week 4, Week 12
Mean number of severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours: sum of all micturitions divided by total number of diary days collected at that visit. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Baseline, Week 1, Week 4, Week 12
Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours.
기간: Baseline, Week 1, Week 4, Week 12
Percent change calculated as change in severe urgency episodes (USS rating >= to 4 in diary ) per 24 hours at that visit divided by the baseline number of severe urgency episodes per 24 hours, multiplied by 100. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine).
Baseline, Week 1, Week 4, Week 12
Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours.
기간: Baseline, Week 1, Week 4, Week 12
Mean USS rating calculated as the sum of rating scores on USS per 24 hours divided by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Baseline, Week 1, Week 4, Week 12
Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours.
기간: Baseline, Week 1, Week 4, Week 12
Frequency-Urgency Sum rating per 24 hours calculated as mean rating scores on the USS multiplied by the mean number of micturitions per 24 hours at that visit. USS is 5-item scale measuring urinary urgency; range is 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Change calculated as mean at observation minus mean at baseline.
Baseline, Week 1, Week 4, Week 12
Change From Baseline in Patient Perception of Bladder Condition (PPBC).
기간: Baseline, Week 1, Week, 4, Week 12
Number of subjects in 4-point category: >= to 2 points improvement [major improvement]; 1 point improvement [minor improvement]; no change; deterioration, based on PPBC score (rated on 6-point scale: 1=no problems at all; 6=many severe problems). Score change: score at observation minus score at baseline; re-scaled to 4-point categorical variables.
Baseline, Week 1, Week, 4, Week 12
Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol.
기간: Baseline, Week 1, Week 4, Week 12
Number of subjects in 3-point category: improvement [>=1-point improvement]; no change; deterioration [>=1-point decrease], based on UPS score (rated on 3-point scale: 1=not able to hold urine; 3=able to finish what I am doing). Score change calculated as score at observation minus score at baseline; re-scaled to 3-point categorical variables.
Baseline, Week 1, Week 4, Week 12
Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).
기간: Baseline, Week 12
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)/by raw score range * 100]. Higher transformed scores indicative of greater symptom bother. Negative change in Symptom Bother score indicates improvement. Change calculated as score at observation minus score at baseline.
Baseline, Week 12
Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment).
기간: Baseline, Week 12
HRQL domain and total raw score derived as sum of scores (6-point scale: 1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.
Baseline, Week 12

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

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유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2007년 4월 1일

기본 완료 (실제)

2008년 7월 1일

연구 완료 (실제)

2008년 7월 1일

연구 등록 날짜

최초 제출

2007년 3월 6일

QC 기준을 충족하는 최초 제출

2007년 3월 7일

처음 게시됨 (추정)

2007년 3월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 3월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 3월 4일

마지막으로 확인됨

2015년 3월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • A0221008

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