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

4. März 2015 aktualisiert von: 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

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

1712

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • 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
  • Chile
      • Puerto Montt, Chile, 5480000
        • Pfizer Investigational Site
      • Santiago, Chile
        • Pfizer Investigational Site
    • VI Región
      • Rancagua, VI Región, Chile, 2820945
        • Pfizer Investigational Site
  • Costa Rica
      • Alajuela, Costa Rica
        • Pfizer Investigational Site
      • Cartago, Costa Rica
        • Pfizer Investigational Site
      • San Jose, Costa Rica
        • Pfizer Investigational Site
  • Deutschland
      • Ahaus, Deutschland, 41683
        • Pfizer Investigational Site
      • Alzey, Deutschland, 55232
        • Pfizer Investigational Site
      • Berlin, Deutschland, 10787
        • Pfizer Investigational Site
      • Berlin, Deutschland, 13125
        • Pfizer Investigational Site
      • Berlin, Deutschland, 13347
        • Pfizer Investigational Site
      • Karlsruhe, Deutschland, 76199
        • Pfizer Investigational Site
      • Krumbach, Deutschland, 86381
        • Pfizer Investigational Site
      • Leipzig, Deutschland, 04109
        • Pfizer Investigational Site
      • Leipzig, Deutschland, 04105
        • Pfizer Investigational Site
      • Marburg, Deutschland, 35039
        • Pfizer Investigational Site
      • Muelheim a.d. Ruhr, Deutschland, 45468
        • Pfizer Investigational Site
      • Muenchen, Deutschland, 81241
        • Pfizer Investigational Site
      • Muenchen, Deutschland, 81925
        • Pfizer Investigational Site
      • Rosenheim, Deutschland, 83022
        • Pfizer Investigational Site
  • Dänemark
      • Aalborg, Dänemark, 9100
        • Pfizer Investigational Site
      • Aarhus N, Dänemark, 8200
        • Pfizer Investigational Site
      • Glostrup, Dänemark, 2600
        • Pfizer Investigational Site
      • Herlev, Dänemark, 2730
        • Pfizer Investigational Site
      • Kolding, Dänemark, 6000
        • Pfizer Investigational Site
      • Nykoebing Falster, Dänemark, 4800
        • Pfizer Investigational Site
      • Roskilde, Dänemark, 4000
        • Pfizer Investigational Site
  • Griechenland
      • Rio, Patras, Griechenland, 26500
        • Pfizer Investigational Site
      • Thessaloniki, Griechenland, 56403
        • Pfizer Investigational Site
    • Attiki
      • Athens, Attiki, Griechenland, 10552
        • Pfizer Investigational Site
    • Ipiros
      • Ioannina, Ipiros, Griechenland, 45001
        • Pfizer Investigational Site
  • Hongkong
      • Hong Kong, Hongkong
        • Pfizer Investigational Site
      • Shatin, Hongkong
        • 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
  • 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
  • Kolumbien
    • Cundinamarca
      • Bogota, Cundinamarca, Kolumbien
        • Pfizer Investigational Site
      • Bogota, Cundinamarca, Kolumbien
        • Pfizer Investigational Site
  • Korea, Republik von
      • Daegu, Korea, Republik von, 705-718
        • Pfizer Investigational Site
      • Seoul, Korea, Republik von, 120-752
        • Pfizer Investigational Site
      • Seoul, Korea, Republik von, 136-705
        • Pfizer Investigational Site
      • Seoul, Korea, Republik von, 137-040
        • Pfizer Investigational Site
      • Seoul, Korea, Republik von, 100-380
        • Pfizer Investigational Site
    • Korea
      • Seoul, Korea, Korea, Republik von, 110-744
        • Pfizer Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Pfizer Investigational Site
    • Selangor
      • Batu Caves, Selangor, Malaysia, 68100
        • Pfizer Investigational Site
  • Norwegen
      • Bergen, Norwegen, 5005
        • Pfizer Investigational Site
      • Hamar, Norwegen, 2317
        • Pfizer Investigational Site
      • Lysaker, Norwegen, 1366
        • Pfizer Investigational Site
      • Oslo, Norwegen, NO-0257
        • Pfizer Investigational Site
      • Oslo, Norwegen, 0264
        • Pfizer Investigational Site
      • Sandnes, Norwegen, 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
  • Rumänien
      • Arad, Rumänien, 310175
        • Pfizer Investigational Site
      • Bucuresti, Rumänien, 041345
        • Pfizer Investigational Site
      • Bucuresti, Rumänien, 050653
        • Pfizer Investigational Site
      • Sibiu, Rumänien, 550245
        • Pfizer Investigational Site
      • Timisoara, Rumänien, 300736
        • Pfizer Investigational Site
  • Russische Föderation
      • Moscow, Russische Föderation, 101000
        • Pfizer Investigational Site
      • Moscow, Russische Föderation, 115516
        • Pfizer Investigational Site
      • Moscow, Russische Föderation, 117815
        • Pfizer Investigational Site
      • Rostov-on-Don, Russische Föderation, 344022
        • Pfizer Investigational Site
    • Russia
      • Moscow, Russia, Russische Föderation, 105425
        • Pfizer Investigational Site
      • St. Petersburg, Russia, Russische Föderation
        • Pfizer Investigational Site
  • Schweden
      • Huskvarna, Schweden, 561 36
        • Pfizer Investigational Site
      • Lulea, Schweden, 97180
        • Pfizer Investigational Site
      • Malmo, Schweden, 205 02
        • Pfizer Investigational Site
      • Skovde, Schweden, 541 30
        • Pfizer Investigational Site
      • Stockholm, Schweden
        • Pfizer Investigational Site
  • Schweiz
      • Frauenfeld, Schweiz, CH-8500
        • Pfizer Investigational Site
      • Luzern 16, Schweiz, CH-6000
        • Pfizer Investigational Site
  • Singapur
      • Singapore, Singapur, 119074
        • Pfizer Investigational Site
      • Singapore, Singapur, 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
  • Südafrika
      • Cape Town, Südafrika, 8001
        • Pfizer Investigational Site
      • Pretoria, Südafrika, 0083
        • Pfizer Investigational Site
    • Free State
      • Bloemfontein, Free State, Südafrika, 9300
        • Pfizer Investigational Site
    • Gauteng
      • Vosloorus, Gauteng, Südafrika, 1475
        • Pfizer Investigational Site
    • Gauteng Province
      • Parktown, Gauteng Province, Südafrika, 2193
        • Pfizer Investigational Site
    • Kwa Zulu Natal
      • Durban, Kwa Zulu Natal, Südafrika, 4001
        • Pfizer Investigational Site
      • Pietermaritzburg, Kwa Zulu Natal, Südafrika, 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
  • Tschechische Republik
      • Hradec Kralove, Tschechische Republik, 500 02
        • Pfizer Investigational Site
      • Jablonec nad Nisou, Tschechische Republik, 466 60
        • Pfizer Investigational Site
      • Jindrichuv Hradec, Tschechische Republik, 377 38
        • Pfizer Investigational Site
      • Ostrava, Tschechische Republik, 708 52
        • Pfizer Investigational Site
      • Praha 8, Tschechische Republik, 180 00
        • 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
  • Vereinigte Staaten
    • Alabama
      • Homewood, Alabama, Vereinigte Staaten, 35209
        • Pfizer Investigational Site
      • Huntsville, Alabama, Vereinigte Staaten, 35801
        • Pfizer Investigational Site
      • Mobile, Alabama, Vereinigte Staaten, 36608
        • Pfizer Investigational Site
    • California
      • Carmichael, California, Vereinigte Staaten, 95608
        • Pfizer Investigational Site
      • Orangevale, California, Vereinigte Staaten, 95662
        • Pfizer Investigational Site
      • San Diego, California, Vereinigte Staaten, 92103-6204
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, Vereinigte Staaten, 80012
        • Pfizer Investigational Site
    • Connecticut
      • Waterbury, Connecticut, Vereinigte Staaten, 06708
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, Vereinigte Staaten, 33186
        • Pfizer Investigational Site
      • Wellington, Florida, Vereinigte Staaten, 33414
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30342
        • Pfizer Investigational Site
    • Idaho
      • Coeur D Alene, Idaho, Vereinigte Staaten, 83814
        • Pfizer Investigational Site
      • Sandpoint, Idaho, Vereinigte Staaten, 83864
        • Pfizer Investigational Site
    • Illinois
      • Aurora, Illinois, Vereinigte Staaten, 60504
        • Pfizer Investigational Site
    • Iowa
      • West Des Moines, Iowa, Vereinigte Staaten, 50266
        • Pfizer Investigational Site
    • Kansas
      • Newton, Kansas, Vereinigte Staaten, 67114
        • Pfizer Investigational Site
    • Louisiana
      • Shrevport, Louisiana, Vereinigte Staaten, 71106
        • Pfizer Investigational Site
    • Massachusetts
      • Watertown, Massachusetts, Vereinigte Staaten, 02472
        • Pfizer Investigational Site
    • Minnesota
      • Chaska, Minnesota, Vereinigte Staaten, 55318
        • Pfizer Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, Vereinigte Staaten, 08648
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, Vereinigte Staaten, 87109
        • Pfizer Investigational Site
    • New York
      • Garden City, New York, Vereinigte Staaten, 11530
        • Pfizer Investigational Site
      • Mineola, New York, Vereinigte Staaten, 11501
        • Pfizer Investigational Site
    • North Carolina
      • Burlington, North Carolina, Vereinigte Staaten, 27215
        • Pfizer Investigational Site
      • Concord, North Carolina, Vereinigte Staaten, 28025
        • Pfizer Investigational Site
      • Huntersville, North Carolina, Vereinigte Staaten, 28078
        • Pfizer Investigational Site
    • Ohio
      • Dayton, Ohio, Vereinigte Staaten, 45439
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, Vereinigte Staaten, 18106
        • Pfizer Investigational Site
      • Allentown, Pennsylvania, Vereinigte Staaten, 18103
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15212
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213-3180
        • Pfizer Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, Vereinigte Staaten, 02914
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, Vereinigte Staaten, 29425
        • Pfizer Investigational Site
      • Columbia, South Carolina, Vereinigte Staaten, 29201
        • Pfizer Investigational Site
    • Tennessee
      • Kingsport, Tennessee, Vereinigte Staaten, 37660
        • Pfizer Investigational Site
      • Milan, Tennessee, Vereinigte Staaten, 38358
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77024
        • Pfizer Investigational Site
    • Utah
      • Provo, Utah, Vereinigte Staaten, 84604
        • Pfizer Investigational Site
    • Virginia
      • Chesapeake, Virginia, Vereinigte Staaten, 23320
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, Vereinigte Staaten, 98104
        • Pfizer Investigational Site
    • Wisconsin
      • Menomonee Falls, Wisconsin, Vereinigte Staaten, 53051
        • Pfizer Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Fesoterodin
Tablets
Arzneimittel: 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
Arzneimittel: placebo
once daily (OD)for 12 weeks
Aktiver Komparator: Tolterodine
Capsules
Arzneimittel: tolterodine tartrate
4 mg once daily (OD) for 12 weeks

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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).
Zeitfenster: 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.
Zeitfenster: 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).
Zeitfenster: 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).
Zeitfenster: Baseline, Week 12
HRQL domain and total raw score derived as sum of scores (6-point scale: 1=not at all/none of the time; 6=a very great deal/all of the time). Transformed score (Total HRQL or domain)=[(Highest possible raw score-Actual total raw score)/Raw score range]x100. Higher transformed scores indicative of better HRQL. Positive change in HRQL scores indicates improvement. Change: score at observation minus score at baseline.
Baseline, Week 12

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Publikationen und hilfreiche Links

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Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. April 2007

Primärer Abschluss (Tatsächlich)

1. Juli 2008

Studienabschluss (Tatsächlich)

1. Juli 2008

Studienanmeldedaten

Zuerst eingereicht

6. März 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. März 2007

Zuerst gepostet (Schätzen)

8. März 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

24. März 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. März 2015

Zuletzt verifiziert

1. März 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • A0221008

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