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

4 marca 2015 zaktualizowane przez: 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

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

1712

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Fezoterodyna
Tabletki
Lek: 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
Komparator placebo: Placebo
Tablets and capsules
Lek: placebo
once daily (OD)for 12 weeks
Aktywny komparator: Tolterodine
Capsules
Lek: tolterodine tartrate
4 mg once daily (OD) for 12 weeks

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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).
Ramy czasowe: 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.
Ramy czasowe: 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).
Ramy czasowe: 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).
Ramy czasowe: 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

Współpracownicy i badacze

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Sponsor

Pfizer

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 kwietnia 2007

Zakończenie podstawowe (Rzeczywisty)

1 lipca 2008

Ukończenie studiów (Rzeczywisty)

1 lipca 2008

Daty rejestracji na studia

Pierwszy przesłany

6 marca 2007

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 marca 2007

Pierwszy wysłany (Oszacować)

8 marca 2007

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

24 marca 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 marca 2015

Ostatnia weryfikacja

1 marca 2015

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • A0221008

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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