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

March 4, 2015 updated by: 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1712

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fesoterodine
Tablets
Drug: 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 Comparator: Placebo
Tablets and capsules
Drug: placebo
once daily (OD)for 12 weeks
Active Comparator: Tolterodine
Capsules
Drug: tolterodine tartrate
4 mg once daily (OD) for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and Week 4.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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).
Time Frame: 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.
Time Frame: 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).
Time Frame: 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).
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

March 6, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 8, 2007

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0221008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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