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

4. marts 2015 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1712

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Fesoterodin
Tabletter
Medicin: 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
Placebo komparator: Placebo
Tablets and capsules
Medicin: placebo
once daily (OD)for 12 weeks
Aktiv komparator: Tolterodine
Capsules
Medicin: tolterodine tartrate
4 mg once daily (OD) for 12 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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).
Tidsramme: 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.
Tidsramme: 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).
Tidsramme: 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).
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2007

Primær færdiggørelse (Faktiske)

1. juli 2008

Studieafslutning (Faktiske)

1. juli 2008

Datoer for studieregistrering

Først indsendt

6. marts 2007

Først indsendt, der opfyldte QC-kriterier

7. marts 2007

Først opslået (Skøn)

8. marts 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A0221008

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner