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

4 mars 2015 mis à jour par: 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

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

1712

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Afrique du Sud
      • Cape Town, Afrique du Sud, 8001
        • Pfizer Investigational Site
      • Pretoria, Afrique du Sud, 0083
        • Pfizer Investigational Site
    • Free State
      • Bloemfontein, Free State, Afrique du Sud, 9300
        • Pfizer Investigational Site
    • Gauteng
      • Vosloorus, Gauteng, Afrique du Sud, 1475
        • Pfizer Investigational Site
    • Gauteng Province
      • Parktown, Gauteng Province, Afrique du Sud, 2193
        • Pfizer Investigational Site
    • Kwa Zulu Natal
      • Durban, Kwa Zulu Natal, Afrique du Sud, 4001
        • Pfizer Investigational Site
      • Pietermaritzburg, Kwa Zulu Natal, Afrique du Sud, 3201
        • Pfizer Investigational Site
  • Allemagne
      • Ahaus, Allemagne, 41683
        • Pfizer Investigational Site
      • Alzey, Allemagne, 55232
        • Pfizer Investigational Site
      • Berlin, Allemagne, 10787
        • Pfizer Investigational Site
      • Berlin, Allemagne, 13125
        • Pfizer Investigational Site
      • Berlin, Allemagne, 13347
        • Pfizer Investigational Site
      • Karlsruhe, Allemagne, 76199
        • Pfizer Investigational Site
      • Krumbach, Allemagne, 86381
        • Pfizer Investigational Site
      • Leipzig, Allemagne, 04109
        • Pfizer Investigational Site
      • Leipzig, Allemagne, 04105
        • Pfizer Investigational Site
      • Marburg, Allemagne, 35039
        • Pfizer Investigational Site
      • Muelheim a.d. Ruhr, Allemagne, 45468
        • Pfizer Investigational Site
      • Muenchen, Allemagne, 81241
        • Pfizer Investigational Site
      • Muenchen, Allemagne, 81925
        • Pfizer Investigational Site
      • Rosenheim, Allemagne, 83022
        • Pfizer Investigational Site
  • Belgique
      • Antwerpen, Belgique, 2020
        • Pfizer Investigational Site
      • Bruxelles, Belgique, 1070
        • Pfizer Investigational Site
      • Kortrijk, Belgique, 8500
        • Pfizer Investigational Site
      • Tessenderlo, Belgique, 3980
        • Pfizer Investigational Site
  • Brésil
    • BA
      • Salvador, BA, Brésil, 40420-000
        • Pfizer Investigational Site
    • RJ
      • Rio de Janeiro, RJ, Brésil, CEP 20551-030
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brésil, 90020-090
        • Pfizer Investigational Site
      • Porto Alegre, RS, Brésil, 90470-340
        • Pfizer Investigational Site
    • SP
      • Campinas, SP, Brésil, 13084-882
        • Pfizer Investigational Site
      • São Paulo, SP, Brésil, 04262-000
        • Pfizer Investigational Site
      • São Paulo, SP, Brésil, 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
  • Chili
      • Puerto Montt, Chili, 5480000
        • Pfizer Investigational Site
      • Santiago, Chili
        • Pfizer Investigational Site
    • VI Región
      • Rancagua, VI Región, Chili, 2820945
        • Pfizer Investigational Site
  • Colombie
    • Cundinamarca
      • Bogota, Cundinamarca, Colombie
        • Pfizer Investigational Site
      • Bogota, Cundinamarca, Colombie
        • Pfizer Investigational Site
  • Corée, République de
      • Daegu, Corée, République de, 705-718
        • Pfizer Investigational Site
      • Seoul, Corée, République de, 120-752
        • Pfizer Investigational Site
      • Seoul, Corée, République de, 136-705
        • Pfizer Investigational Site
      • Seoul, Corée, République de, 137-040
        • Pfizer Investigational Site
      • Seoul, Corée, République de, 100-380
        • Pfizer Investigational Site
    • Korea
      • Seoul, Korea, Corée, République de, 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
  • Danemark
      • Aalborg, Danemark, 9100
        • Pfizer Investigational Site
      • Aarhus N, Danemark, 8200
        • Pfizer Investigational Site
      • Glostrup, Danemark, 2600
        • Pfizer Investigational Site
      • Herlev, Danemark, 2730
        • Pfizer Investigational Site
      • Kolding, Danemark, 6000
        • Pfizer Investigational Site
      • Nykoebing Falster, Danemark, 4800
        • Pfizer Investigational Site
      • Roskilde, Danemark, 4000
        • Pfizer Investigational Site
  • Espagne
      • Madrid, Espagne, 28046
        • Pfizer Investigational Site
      • Valencia, Espagne, 46010
        • Pfizer Investigational Site
    • Madrid
      • Getafe, Madrid, Espagne, 28905
        • Pfizer Investigational Site
    • Vizcaya
      • Bilbao, Vizcaya, Espagne, 48013
        • Pfizer Investigational Site
  • Fédération Russe
      • Moscow, Fédération Russe, 101000
        • Pfizer Investigational Site
      • Moscow, Fédération Russe, 115516
        • Pfizer Investigational Site
      • Moscow, Fédération Russe, 117815
        • Pfizer Investigational Site
      • Rostov-on-Don, Fédération Russe, 344022
        • Pfizer Investigational Site
    • Russia
      • Moscow, Russia, Fédération Russe, 105425
        • Pfizer Investigational Site
      • St. Petersburg, Russia, Fédération Russe
        • Pfizer Investigational Site
  • Grèce
      • Rio, Patras, Grèce, 26500
        • Pfizer Investigational Site
      • Thessaloniki, Grèce, 56403
        • Pfizer Investigational Site
    • Attiki
      • Athens, Attiki, Grèce, 10552
        • Pfizer Investigational Site
    • Ipiros
      • Ioannina, Ipiros, Grèce, 45001
        • Pfizer Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Pfizer Investigational Site
      • Shatin, Hong Kong
        • Pfizer Investigational Site
  • Hongrie
      • Debrecen, Hongrie, 4026
        • Pfizer Investigational Site
      • Nyiregyhaza, Hongrie, 4400
        • Pfizer Investigational Site
      • Szeged, Hongrie, 6725
        • Pfizer Investigational Site
      • Szentes, Hongrie, 6600
        • Pfizer Investigational Site
  • Inde
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, Inde, 500 001
        • Pfizer Investigational Site
      • Hyderabad, Andhra Pradesh, Inde, 500 082
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, Inde, 560 034
        • Pfizer Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, Inde, 302 004
        • Pfizer Investigational Site
    • Tamil Nadu
      • Vellore, Tamil Nadu, Inde, 632 004
        • Pfizer Investigational Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, Inde, 226003
        • Pfizer Investigational Site
  • Italie
      • Latina, Italie, 04100
        • Pfizer Investigational Site
      • Padova, Italie, 35128
        • Pfizer Investigational Site
      • Siena, Italie, 53100
        • Pfizer Investigational Site
  • Malaisie
      • Kuala Lumpur, Malaisie, 59100
        • Pfizer Investigational Site
    • Selangor
      • Batu Caves, Selangor, Malaisie, 68100
        • Pfizer Investigational Site
  • Norvège
      • Bergen, Norvège, 5005
        • Pfizer Investigational Site
      • Hamar, Norvège, 2317
        • Pfizer Investigational Site
      • Lysaker, Norvège, 1366
        • Pfizer Investigational Site
      • Oslo, Norvège, NO-0257
        • Pfizer Investigational Site
      • Oslo, Norvège, 0264
        • Pfizer Investigational Site
      • Sandnes, Norvège, 4313
        • Pfizer Investigational Site
  • Pologne
      • Bialystok, Pologne, 15-950
        • Pfizer Investigational Site
      • Bydgoszcz, Pologne, 85-168
        • Pfizer Investigational Site
      • Lodz, Pologne, 91-463
        • Pfizer Investigational Site
      • Szczecin, Pologne, 70-11
        • Pfizer Investigational Site
      • Warszawa, Pologne, 02-507
        • Pfizer Investigational Site
  • Pérou
      • Lima, Pérou, L27
        • Pfizer Investigational Site
    • Lima
      • Surco, Lima, Pérou, L33
        • Pfizer Investigational Site
  • Roumanie
      • Arad, Roumanie, 310175
        • Pfizer Investigational Site
      • Bucuresti, Roumanie, 041345
        • Pfizer Investigational Site
      • Bucuresti, Roumanie, 050653
        • Pfizer Investigational Site
      • Sibiu, Roumanie, 550245
        • Pfizer Investigational Site
      • Timisoara, Roumanie, 300736
        • Pfizer Investigational Site
  • République tchèque
      • Hradec Kralove, République tchèque, 500 02
        • Pfizer Investigational Site
      • Jablonec nad Nisou, République tchèque, 466 60
        • Pfizer Investigational Site
      • Jindrichuv Hradec, République tchèque, 377 38
        • Pfizer Investigational Site
      • Ostrava, République tchèque, 708 52
        • Pfizer Investigational Site
      • Praha 8, République tchèque, 180 00
        • Pfizer Investigational Site
  • Singapour
      • Singapore, Singapour, 119074
        • Pfizer Investigational Site
      • Singapore, Singapour, 229899
        • Pfizer Investigational Site
  • Suisse
      • Frauenfeld, Suisse, CH-8500
        • Pfizer Investigational Site
      • Luzern 16, Suisse, CH-6000
        • Pfizer Investigational Site
  • Suède
      • Huskvarna, Suède, 561 36
        • Pfizer Investigational Site
      • Lulea, Suède, 97180
        • Pfizer Investigational Site
      • Malmo, Suède, 205 02
        • Pfizer Investigational Site
      • Skovde, Suède, 541 30
        • Pfizer Investigational Site
      • Stockholm, Suède
        • Pfizer Investigational Site
  • Taïwan
      • Hualien, Taïwan, 970
        • Pfizer Investigational Site
      • Taichung City, Taïwan, 40705
        • Pfizer Investigational Site
      • Taipei, Taïwan, 100
        • Pfizer Investigational Site
      • Taipei, Taïwan
        • Pfizer Investigational Site
    • Kaohsiung
      • Niao-Sung Hsiang, Kaohsiung, Taïwan, 833
        • 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
  • États-Unis
    • Alabama
      • Homewood, Alabama, États-Unis, 35209
        • Pfizer Investigational Site
      • Huntsville, Alabama, États-Unis, 35801
        • Pfizer Investigational Site
      • Mobile, Alabama, États-Unis, 36608
        • Pfizer Investigational Site
    • California
      • Carmichael, California, États-Unis, 95608
        • Pfizer Investigational Site
      • Orangevale, California, États-Unis, 95662
        • Pfizer Investigational Site
      • San Diego, California, États-Unis, 92103-6204
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, États-Unis, 80012
        • Pfizer Investigational Site
    • Connecticut
      • Waterbury, Connecticut, États-Unis, 06708
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, États-Unis, 33186
        • Pfizer Investigational Site
      • Wellington, Florida, États-Unis, 33414
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, États-Unis, 30342
        • Pfizer Investigational Site
    • Idaho
      • Coeur D Alene, Idaho, États-Unis, 83814
        • Pfizer Investigational Site
      • Sandpoint, Idaho, États-Unis, 83864
        • Pfizer Investigational Site
    • Illinois
      • Aurora, Illinois, États-Unis, 60504
        • Pfizer Investigational Site
    • Iowa
      • West Des Moines, Iowa, États-Unis, 50266
        • Pfizer Investigational Site
    • Kansas
      • Newton, Kansas, États-Unis, 67114
        • Pfizer Investigational Site
    • Louisiana
      • Shrevport, Louisiana, États-Unis, 71106
        • Pfizer Investigational Site
    • Massachusetts
      • Watertown, Massachusetts, États-Unis, 02472
        • Pfizer Investigational Site
    • Minnesota
      • Chaska, Minnesota, États-Unis, 55318
        • Pfizer Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, États-Unis, 08648
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, États-Unis, 87109
        • Pfizer Investigational Site
    • New York
      • Garden City, New York, États-Unis, 11530
        • Pfizer Investigational Site
      • Mineola, New York, États-Unis, 11501
        • Pfizer Investigational Site
    • North Carolina
      • Burlington, North Carolina, États-Unis, 27215
        • Pfizer Investigational Site
      • Concord, North Carolina, États-Unis, 28025
        • Pfizer Investigational Site
      • Huntersville, North Carolina, États-Unis, 28078
        • Pfizer Investigational Site
    • Ohio
      • Dayton, Ohio, États-Unis, 45439
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, États-Unis, 18106
        • Pfizer Investigational Site
      • Allentown, Pennsylvania, États-Unis, 18103
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, États-Unis, 15212
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, États-Unis, 15213-3180
        • Pfizer Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, États-Unis, 02914
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, États-Unis, 29425
        • Pfizer Investigational Site
      • Columbia, South Carolina, États-Unis, 29201
        • Pfizer Investigational Site
    • Tennessee
      • Kingsport, Tennessee, États-Unis, 37660
        • Pfizer Investigational Site
      • Milan, Tennessee, États-Unis, 38358
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, États-Unis, 77024
        • Pfizer Investigational Site
    • Utah
      • Provo, Utah, États-Unis, 84604
        • Pfizer Investigational Site
    • Virginia
      • Chesapeake, Virginia, États-Unis, 23320
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, États-Unis, 98104
        • Pfizer Investigational Site
    • Wisconsin
      • Menomonee Falls, Wisconsin, États-Unis, 53051
        • Pfizer Investigational Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Fésotérodine
Comprimés
Médicament: 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
Comparateur placebo: Placebo
Tablets and capsules
Médicament: placebo
once daily (OD)for 12 weeks
Comparateur actif: Tolterodine
Capsules
Médicament: tolterodine tartrate
4 mg once daily (OD) for 12 weeks

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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).
Délai: 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.
Délai: 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).
Délai: 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).
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Pfizer

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2007

Achèvement primaire (Réel)

1 juillet 2008

Achèvement de l'étude (Réel)

1 juillet 2008

Dates d'inscription aux études

Première soumission

6 mars 2007

Première soumission répondant aux critères de contrôle qualité

7 mars 2007

Première publication (Estimation)

8 mars 2007

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

24 mars 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 mars 2015

Dernière vérification

1 mars 2015

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • A0221008

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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