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A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).


Phase 4
18 Years
N/A
Not Enrolling
Both
Urinary Bladder, Overactive

Thank you

Trial Information

A 14 Week Randomized Parallel Group Placebo-Controlled Double-Blind Multicentre Study Of Fesoterodine 8 Mg In Overactive Bladder Patients With Sub-Optimal Response To Tolterodine 4 Mg Extended Release (ER).


Inclusion Criteria:



- Diagnosis of overactive bladder with symptoms for at least 6 months.

- Moderate to severe incontinence episode frequency and subsequent sub-optimal response
to tolterodine

- Women of child-bearing potential must not intend to become pregnant, be pregnant or
producing breast milk at the time of study entry, and must use contraception

Exclusion Criteria:

- Conditions or prior treatment that may also affect bladder function

- Clinically significant urinary tract infection (UTI)

- Ongoing treatment with overactive bladder medications (these can be stopped at the
first visit to allow entry into the study).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours

Outcome Description:

UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

Outcome Time Frame:

Baseline, Week 12

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A0221094

NCT ID:

NCT01302054

Start Date:

May 2011

Completion Date:

May 2012

Related Keywords:

  • Urinary Bladder, Overactive
  • Bladder Overactive
  • Overactive urinary bladder
  • Overactive Bladder
  • Urinary Bladder, Overactive

Name

Location

Urology of Indiana, LLCIndianapolis, Indiana  46202
Pinellas Urology, Inc.St. Petersburg, Florida  33710
Urology Specialists Of The CarolinasCharlotte,, North Carolina  28207
Palm Beach Research CenterWest Palm Beach, Florida  33409
Women's Specialty CenterJackson, Mississippi  39202
Regional Urology, LLCShreveport, Louisiana  71106
Renstar Medical Research, Inc.Ocala, Florida  34471
Advanced Clinical ResearchWest Jordan, Utah  84088
University Urology AssociatesNew York, New York  10016
Medical Center for Clinical ResearchSan Diego, California  92108
Chase Medical Research, LlcWaterbury, Connecticut  06708
Fox Valley Clinical Research Center, LlcAurora, Illinois  60504
Lillestol Research LlcFargo, North Dakota  58103
Integrity Medical Research, LLCMountlake Terrace, Washington  98043
Pharma ResourceEast Providence, Rhode Island  02915
Advances in Health, Inc.Houston, Texas  77030
Chattanooga Medical Research, LLCChattanooga, Tennessee  37404
CRC of JacksonJackson, Mississippi  39202
Bay State Clinical Trials, Inc.Watertown, Massachusetts  02472
Urologic Consultants of Southeastern PennsylvaniaPhiladelphia, Pennsylvania  19004
Radiant Research, Inc.Greer, South Carolina  29651
American Institute of ResearchWhittier, California  90603
Radiant Research, Inc.Birmingham, Alabama  35209
Alabama Internal Medicine, PCBirmingham, Alabama  35235
Brown and McCool GynecologyFairhope, Alabama  36532
Radiant Research, Inc.Chandler, Arizona  85225
Eclipse Clinical ResearchGreen Valley, Arizona  85614
Urological Associates of Southern Arizona, PCTucson, Arizona  85715
Institute for Advanced UrologyLos Angeles, California  90048
Moaz Khorsandi, DOLos Angeles, California  90017
Urology Group of Southern CaliforniaLos Angeles, California  90017
Center for Clinical Trials, LLCParamount, California  90723
Sierra Clinical ResearchRoseville, California  95661
Superior Research LLCSacramento, California  95825
California Research FoundationSan Diego, California  92103
Advanced Urology, PCParker, Colorado  80134
Thameside Obstetrics/Gynecological CenterGroton, Connecticut  06340
S.H.E. Medical AssociatesHartford, Connecticut  06105
Manatee Medical Research Institute, LLCBradenton, Florida  34205
Atlantic Institute of Clinical ResearchDaytona Beach, Florida  32114
SJS Clinical ResearchDestin, Florida  32541
Ocala Urology SpecialistsOcala, Florida  34471
Accord Clinical Research, LLCPort Orange, Florida  32129
Florida Urology PartnersTampa, Florida  33607
The Office of Georgis Patsias, MD, PAWellington, Florida  33449
Atlanta Medical Research Institute, LLCAlpharetta, Georgia  30005
Radiant Research, Inc.Atlanta, Georgia  30342
In-Quest Medical Research, LLCDuluth, Georgia  30096
Valley Health CareRome, Georgia  30165
Prism Research GroupRome, Georgia  30165
Radiant Research, Inc.Chicago, Illinois  60654
Radiant Research, Inc.Overland Park, Kansas  66202
New England Center for Clinical Research Fall River, LLCFall River, Massachusetts  02720
New England Center for Clinical Research of Massachusetts, LLCNew Bedford, Massachusetts  02740
Beyer ResearchKalamazoo, Michigan  49009
Medical Research Associates, Inc.Traverse City, Michigan  49684
Radiant Research, Inc.Edina, Minnesota  55435
Adult and Pediatric UrologySartell, Minnesota  56377
The Urology GroupSouthaven, Mississippi  38671
Radiant Research, Inc.St. Louis, Missouri  63141
Quality Clinical Research, Inc.Omaha, Nebraska  68114
Impact Clinical TrialsLas Vegas, Nevada  89106
Francis Jimenez, MDLas Vegas, Nevada  89102
Richard M. Groom, MDLas Vegas, Nevada  89106
Northeast UrogynecologyAlbany, New York  12205
The Urologic Institute of Northeastern New York - Community Care Physicians, PCAlbany, New York  12208
Associated Medical Professionals of New York, PLLCOneida, New York  13421
Associated Medical Professionals of NYSyracuse, New York  13210
PMG Research of Raleigh, LLC d/b/a PMG Research of CaryCary, North Carolina  27518
PMG Research of CharlotteCharlotte, North Carolina  28209
PMG Research of Raleigh, LLCRaleigh, North Carolina  27609
Salibury Urological ClinicSalisbury, North Carolina  28144
PMG Research of Salisbury, LLCSalisbury, North Carolina  28144
Carolina Urological AssociatesWinston-Salem, North Carolina  27103
PMG Research of Winston-Salem, LLCWinston-Salem, North Carolina  27103
Radiant Research, Inc.Akron, Ohio  44311
Providence Health Partners - Center for Clinical ResearchDayton, Ohio  45439
Central Sooner ResearchNorman, Oklahoma  73071
Pacific Women's Center, LLCEugene, Oregon  97401
OB/GYN Associates of ErieErie, Pennsylvania  16507
Research Protocol Management SpecialistsPittsburgh, Pennsylvania  15243
Gilbert Teixeira, DOEast Providence, Rhode Island  02914
Memorial Hospital of Rhode Island - Clinical Studies CenterPawtucket, Rhode Island  02860
SC Clinical Research Center, LLCColumbia, South Carolina  29201
Columbia Women's Healthcare, LLCColumbia, South Carolina  29201
PMG Research of Charleston, LLCMount Pleasant, South Carolina  29464
OB-GYN Centre of ExcellenceChattanooga, Tennessee  37404
Advanced Therapeutics, Inc.Johnson City, Tennessee  37601
Johnson City Internal MedicineJohnson City, Tennessee  37604
Adult Care of AustinAustin, Texas  78745
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DiscoveResearch, Inc.Beaumont, Texas  77701
Beaumont Internal Medicine & Geriatric AssociatesBeaumont, Texas  77702
DiscoveResearch, IncorporatedBryan, Texas  77802
Radiant Research, Inc.Dallas, Texas  75231
Centex Research, Inc. - Pineloch Medical ClinicHouston, Texas  77062
The Office of Dr. Steven Maislos, MDHouston, Texas  77074
Village Health PartnersPlano, Texas  75024
Paragon Research Center, LLCSan Antonio, Texas  78205
Radiant Research, Inc.Murray, Utah  84123
Integra Trials, LLCArlington, Virginia  22205
Washington UrologyArlington, Virginia  22205
Urology Northwest, PAMountlake Terrace, Washington  98043
North Spokane Women's ClinicSpokane, Washington  99207