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

4 marzo 2015 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1712

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Belgio
      • Antwerpen, Belgio, 2020
        • Pfizer Investigational Site
      • Bruxelles, Belgio, 1070
        • Pfizer Investigational Site
      • Kortrijk, Belgio, 8500
        • Pfizer Investigational Site
      • Tessenderlo, Belgio, 3980
        • Pfizer Investigational Site
  • Brasile
    • BA
      • Salvador, BA, Brasile, 40420-000
        • Pfizer Investigational Site
    • RJ
      • Rio de Janeiro, RJ, Brasile, CEP 20551-030
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brasile, 90020-090
        • Pfizer Investigational Site
      • Porto Alegre, RS, Brasile, 90470-340
        • Pfizer Investigational Site
    • SP
      • Campinas, SP, Brasile, 13084-882
        • Pfizer Investigational Site
      • São Paulo, SP, Brasile, 04262-000
        • Pfizer Investigational Site
      • São Paulo, SP, Brasile, 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
  • Corea, Repubblica di
      • Daegu, Corea, Repubblica di, 705-718
        • Pfizer Investigational Site
      • Seoul, Corea, Repubblica di, 120-752
        • Pfizer Investigational Site
      • Seoul, Corea, Repubblica di, 136-705
        • Pfizer Investigational Site
      • Seoul, Corea, Repubblica di, 137-040
        • Pfizer Investigational Site
      • Seoul, Corea, Repubblica di, 100-380
        • Pfizer Investigational Site
    • Korea
      • Seoul, Korea, Corea, Repubblica di, 110-744
        • Pfizer Investigational Site
  • Costa Rica
      • Alajuela, Costa Rica
        • Pfizer Investigational Site
      • Cartago, Costa Rica
        • Pfizer Investigational Site
      • San Jose, Costa Rica
        • Pfizer Investigational Site
  • Danimarca
      • Aalborg, Danimarca, 9100
        • Pfizer Investigational Site
      • Aarhus N, Danimarca, 8200
        • Pfizer Investigational Site
      • Glostrup, Danimarca, 2600
        • Pfizer Investigational Site
      • Herlev, Danimarca, 2730
        • Pfizer Investigational Site
      • Kolding, Danimarca, 6000
        • Pfizer Investigational Site
      • Nykoebing Falster, Danimarca, 4800
        • Pfizer Investigational Site
      • Roskilde, Danimarca, 4000
        • Pfizer Investigational Site
  • Federazione Russa
      • Moscow, Federazione Russa, 101000
        • Pfizer Investigational Site
      • Moscow, Federazione Russa, 115516
        • Pfizer Investigational Site
      • Moscow, Federazione Russa, 117815
        • Pfizer Investigational Site
      • Rostov-on-Don, Federazione Russa, 344022
        • Pfizer Investigational Site
    • Russia
      • Moscow, Russia, Federazione Russa, 105425
        • Pfizer Investigational Site
      • St. Petersburg, Russia, Federazione Russa
        • Pfizer Investigational Site
  • Germania
      • Ahaus, Germania, 41683
        • Pfizer Investigational Site
      • Alzey, Germania, 55232
        • Pfizer Investigational Site
      • Berlin, Germania, 10787
        • Pfizer Investigational Site
      • Berlin, Germania, 13125
        • Pfizer Investigational Site
      • Berlin, Germania, 13347
        • Pfizer Investigational Site
      • Karlsruhe, Germania, 76199
        • Pfizer Investigational Site
      • Krumbach, Germania, 86381
        • Pfizer Investigational Site
      • Leipzig, Germania, 04109
        • Pfizer Investigational Site
      • Leipzig, Germania, 04105
        • Pfizer Investigational Site
      • Marburg, Germania, 35039
        • Pfizer Investigational Site
      • Muelheim a.d. Ruhr, Germania, 45468
        • Pfizer Investigational Site
      • Muenchen, Germania, 81241
        • Pfizer Investigational Site
      • Muenchen, Germania, 81925
        • Pfizer Investigational Site
      • Rosenheim, Germania, 83022
        • Pfizer Investigational Site
  • Grecia
      • Rio, Patras, Grecia, 26500
        • Pfizer Investigational Site
      • Thessaloniki, Grecia, 56403
        • Pfizer Investigational Site
    • Attiki
      • Athens, Attiki, Grecia, 10552
        • Pfizer Investigational Site
    • Ipiros
      • Ioannina, Ipiros, Grecia, 45001
        • Pfizer Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Pfizer Investigational Site
      • Shatin, Hong Kong
        • Pfizer Investigational Site
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 001
        • Pfizer Investigational Site
      • Hyderabad, Andhra Pradesh, India, 500 082
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 034
        • Pfizer Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302 004
        • Pfizer Investigational Site
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632 004
        • Pfizer Investigational Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • Pfizer Investigational Site
  • Italia
      • Latina, Italia, 04100
        • Pfizer Investigational Site
      • Padova, Italia, 35128
        • Pfizer Investigational Site
      • Siena, Italia, 53100
        • Pfizer Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Pfizer Investigational Site
    • Selangor
      • Batu Caves, Selangor, Malaysia, 68100
        • Pfizer Investigational Site
  • Norvegia
      • Bergen, Norvegia, 5005
        • Pfizer Investigational Site
      • Hamar, Norvegia, 2317
        • Pfizer Investigational Site
      • Lysaker, Norvegia, 1366
        • Pfizer Investigational Site
      • Oslo, Norvegia, NO-0257
        • Pfizer Investigational Site
      • Oslo, Norvegia, 0264
        • Pfizer Investigational Site
      • Sandnes, Norvegia, 4313
        • Pfizer Investigational Site
  • Perù
      • Lima, Perù, L27
        • Pfizer Investigational Site
    • Lima
      • Surco, Lima, Perù, L33
        • Pfizer Investigational Site
  • Polonia
      • Bialystok, Polonia, 15-950
        • Pfizer Investigational Site
      • Bydgoszcz, Polonia, 85-168
        • Pfizer Investigational Site
      • Lodz, Polonia, 91-463
        • Pfizer Investigational Site
      • Szczecin, Polonia, 70-11
        • Pfizer Investigational Site
      • Warszawa, Polonia, 02-507
        • Pfizer Investigational Site
  • Repubblica Ceca
      • Hradec Kralove, Repubblica Ceca, 500 02
        • Pfizer Investigational Site
      • Jablonec nad Nisou, Repubblica Ceca, 466 60
        • Pfizer Investigational Site
      • Jindrichuv Hradec, Repubblica Ceca, 377 38
        • Pfizer Investigational Site
      • Ostrava, Repubblica Ceca, 708 52
        • Pfizer Investigational Site
      • Praha 8, Repubblica Ceca, 180 00
        • Pfizer Investigational Site
  • Romania
      • Arad, Romania, 310175
        • Pfizer Investigational Site
      • Bucuresti, Romania, 041345
        • Pfizer Investigational Site
      • Bucuresti, Romania, 050653
        • Pfizer Investigational Site
      • Sibiu, Romania, 550245
        • Pfizer Investigational Site
      • Timisoara, Romania, 300736
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 119074
        • Pfizer Investigational Site
      • Singapore, Singapore, 229899
        • Pfizer Investigational Site
  • Spagna
      • Madrid, Spagna, 28046
        • Pfizer Investigational Site
      • Valencia, Spagna, 46010
        • Pfizer Investigational Site
    • Madrid
      • Getafe, Madrid, Spagna, 28905
        • Pfizer Investigational Site
    • Vizcaya
      • Bilbao, Vizcaya, Spagna, 48013
        • Pfizer Investigational Site
  • Stati Uniti
    • Alabama
      • Homewood, Alabama, Stati Uniti, 35209
        • Pfizer Investigational Site
      • Huntsville, Alabama, Stati Uniti, 35801
        • Pfizer Investigational Site
      • Mobile, Alabama, Stati Uniti, 36608
        • Pfizer Investigational Site
    • California
      • Carmichael, California, Stati Uniti, 95608
        • Pfizer Investigational Site
      • Orangevale, California, Stati Uniti, 95662
        • Pfizer Investigational Site
      • San Diego, California, Stati Uniti, 92103-6204
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80012
        • Pfizer Investigational Site
    • Connecticut
      • Waterbury, Connecticut, Stati Uniti, 06708
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, Stati Uniti, 33186
        • Pfizer Investigational Site
      • Wellington, Florida, Stati Uniti, 33414
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30342
        • Pfizer Investigational Site
    • Idaho
      • Coeur D Alene, Idaho, Stati Uniti, 83814
        • Pfizer Investigational Site
      • Sandpoint, Idaho, Stati Uniti, 83864
        • Pfizer Investigational Site
    • Illinois
      • Aurora, Illinois, Stati Uniti, 60504
        • Pfizer Investigational Site
    • Iowa
      • West Des Moines, Iowa, Stati Uniti, 50266
        • Pfizer Investigational Site
    • Kansas
      • Newton, Kansas, Stati Uniti, 67114
        • Pfizer Investigational Site
    • Louisiana
      • Shrevport, Louisiana, Stati Uniti, 71106
        • Pfizer Investigational Site
    • Massachusetts
      • Watertown, Massachusetts, Stati Uniti, 02472
        • Pfizer Investigational Site
    • Minnesota
      • Chaska, Minnesota, Stati Uniti, 55318
        • Pfizer Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, Stati Uniti, 08648
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87109
        • Pfizer Investigational Site
    • New York
      • Garden City, New York, Stati Uniti, 11530
        • Pfizer Investigational Site
      • Mineola, New York, Stati Uniti, 11501
        • Pfizer Investigational Site
    • North Carolina
      • Burlington, North Carolina, Stati Uniti, 27215
        • Pfizer Investigational Site
      • Concord, North Carolina, Stati Uniti, 28025
        • Pfizer Investigational Site
      • Huntersville, North Carolina, Stati Uniti, 28078
        • Pfizer Investigational Site
    • Ohio
      • Dayton, Ohio, Stati Uniti, 45439
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, Stati Uniti, 18106
        • Pfizer Investigational Site
      • Allentown, Pennsylvania, Stati Uniti, 18103
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Stati Uniti, 15212
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213-3180
        • Pfizer Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, Stati Uniti, 02914
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • Pfizer Investigational Site
      • Columbia, South Carolina, Stati Uniti, 29201
        • Pfizer Investigational Site
    • Tennessee
      • Kingsport, Tennessee, Stati Uniti, 37660
        • Pfizer Investigational Site
      • Milan, Tennessee, Stati Uniti, 38358
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, Stati Uniti, 77024
        • Pfizer Investigational Site
    • Utah
      • Provo, Utah, Stati Uniti, 84604
        • Pfizer Investigational Site
    • Virginia
      • Chesapeake, Virginia, Stati Uniti, 23320
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, Stati Uniti, 98104
        • Pfizer Investigational Site
    • Wisconsin
      • Menomonee Falls, Wisconsin, Stati Uniti, 53051
        • Pfizer Investigational Site
  • Sud Africa
      • Cape Town, Sud Africa, 8001
        • Pfizer Investigational Site
      • Pretoria, Sud Africa, 0083
        • Pfizer Investigational Site
    • Free State
      • Bloemfontein, Free State, Sud Africa, 9300
        • Pfizer Investigational Site
    • Gauteng
      • Vosloorus, Gauteng, Sud Africa, 1475
        • Pfizer Investigational Site
    • Gauteng Province
      • Parktown, Gauteng Province, Sud Africa, 2193
        • Pfizer Investigational Site
    • Kwa Zulu Natal
      • Durban, Kwa Zulu Natal, Sud Africa, 4001
        • Pfizer Investigational Site
      • Pietermaritzburg, Kwa Zulu Natal, Sud Africa, 3201
        • Pfizer Investigational Site
  • Svezia
      • Huskvarna, Svezia, 561 36
        • Pfizer Investigational Site
      • Lulea, Svezia, 97180
        • Pfizer Investigational Site
      • Malmo, Svezia, 205 02
        • Pfizer Investigational Site
      • Skovde, Svezia, 541 30
        • Pfizer Investigational Site
      • Stockholm, Svezia
        • Pfizer Investigational Site
  • Svizzera
      • Frauenfeld, Svizzera, CH-8500
        • Pfizer Investigational Site
      • Luzern 16, Svizzera, CH-6000
        • 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
  • Ucraina
      • Chernivtsi, Ucraina, 58002
        • Pfizer Investigational Site
      • Kharkiv, Ucraina, 61037
        • Pfizer Investigational Site
      • Kyiv, Ucraina, 04053
        • Pfizer Investigational Site
      • Odessa, Ucraina, 65000
        • Pfizer Investigational Site
      • Zaporizhzhia, Ucraina, 69000
        • Pfizer Investigational Site
  • Ungheria
      • Debrecen, Ungheria, 4026
        • Pfizer Investigational Site
      • Nyiregyhaza, Ungheria, 4400
        • Pfizer Investigational Site
      • Szeged, Ungheria, 6725
        • Pfizer Investigational Site
      • Szentes, Ungheria, 6600
        • Pfizer Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Fesoterodina
Compresse
Droga: 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
Comparatore placebo: Placebo
Tablets and capsules
Droga: placebo
once daily (OD)for 12 weeks
Comparatore attivo: Tolterodine
Capsules
Droga: tolterodine tartrate
4 mg once daily (OD) for 12 weeks

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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).
Lasso di tempo: 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.
Lasso di tempo: 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).
Lasso di tempo: 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).
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

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Pubblicazioni generali

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2007

Completamento primario (Effettivo)

1 luglio 2008

Completamento dello studio (Effettivo)

1 luglio 2008

Date di iscrizione allo studio

Primo inviato

6 marzo 2007

Primo inviato che soddisfa i criteri di controllo qualità

7 marzo 2007

Primo Inserito (Stima)

8 marzo 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

24 marzo 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 marzo 2015

Ultimo verificato

1 marzo 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A0221008

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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