AzTrials
AzTrials

Overactive BladderPhase 3NCT00444925

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

A Phase 3 study testing fesoterodine fumarate and tolterodine tartrate in people with Overactive Bladder, run by Pfizer at 178 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overactive Bladder
What is being tested?
fesoterodine fumarate and tolterodine tartrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,712 participants
Where
178 sitesin 29 countries
Study dates
Apr 2007to Jul 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult overactive bladder (OAB) patients who present with OAB symptoms, including urinary frequency >= 8 per day and urgency urinary incontinence >=1 per day

Who cannot join

  • 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.

Trial locations and contacts

178 sites in 29 countries.

178 sites in 29 countries

United States41 sites

  • Pfizer Investigational Site

    Albuquerque, New Mexico, 87109

  • Pfizer Investigational Site

    Allentown, Pennsylvania, 18103

  • Pfizer Investigational Site

    Allentown, Pennsylvania, 18106

  • Pfizer Investigational Site

    Atlanta, Georgia, 30342

  • Pfizer Investigational Site

    Aurora, Colorado, 80012

  • Pfizer Investigational Site

    Aurora, Illinois, 60504

  • Pfizer Investigational Site

    Burlington, North Carolina, 27215

  • Pfizer Investigational Site

    Carmichael, California, 95608

  • Pfizer Investigational Site

    Charleston, South Carolina, 29425

  • Pfizer Investigational Site

    Chaska, Minnesota, 55318

  • Pfizer Investigational Site

    Chesapeake, Virginia, 23320

  • Pfizer Investigational Site

    Coeur d'Alene, Idaho, 83814

  • Pfizer Investigational Site

    Columbia, South Carolina, 29201

  • Pfizer Investigational Site

    Concord, North Carolina, 28025

  • Pfizer Investigational Site

    Dayton, Ohio, 45439

  • Pfizer Investigational Site

    East Providence, Rhode Island, 02914

  • Pfizer Investigational Site

    Garden City, New York, 11530

  • Pfizer Investigational Site

    Homewood, Alabama, 35209

  • Pfizer Investigational Site

    Houston, Texas, 77024

  • Pfizer Investigational Site

    Huntersville, North Carolina, 28078

  • Pfizer Investigational Site

    Huntsville, Alabama, 35801

  • Pfizer Investigational Site

    Kingsport, Tennessee, 37660

  • Pfizer Investigational Site

    Lawrenceville, New Jersey, 08648

  • Pfizer Investigational Site

    Menomonee Falls, Wisconsin, 53051

  • Pfizer Investigational Site

    Miami, Florida, 33186

  • Pfizer Investigational Site

    Milan, Tennessee, 38358

  • Pfizer Investigational Site

    Mineola, New York, 11501

  • Pfizer Investigational Site

    Mobile, Alabama, 36608

  • Pfizer Investigational Site

    Newton, Kansas, 67114

  • Pfizer Investigational Site

    Orangevale, California, 95662

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15213-3180

  • Pfizer Investigational Site

    Provo, Utah, 84604

  • Pfizer Investigational Site

    San Diego, California, 92103-6204

  • Pfizer Investigational Site

    Sandpoint, Idaho, 83864

  • Pfizer Investigational Site

    Seattle, Washington, 98104

  • Pfizer Investigational Site

    Shrevport, Louisiana, 71106

  • Pfizer Investigational Site

    Waterbury, Connecticut, 06708

  • Pfizer Investigational Site

    Watertown, Massachusetts, 02472

  • Pfizer Investigational Site

    Wellington, Florida, 33414

  • Pfizer Investigational Site

    West Des Moines, Iowa, 50266

Other trials in United States

Germany14 sites

  • Pfizer Investigational Site

    Ahaus, 41683

  • Pfizer Investigational Site

    Alzey, 55232

  • Pfizer Investigational Site

    Berlin, 10787

  • Pfizer Investigational Site

    Berlin, 13125

  • Pfizer Investigational Site

    Berlin, 13347

  • Pfizer Investigational Site

    Karlsruhe, 76199

  • Pfizer Investigational Site

    Krumbach, 86381

  • Pfizer Investigational Site

    Leipzig, 04105

  • Pfizer Investigational Site

    Leipzig, 04109

  • Pfizer Investigational Site

    Marburg, 35039

  • Pfizer Investigational Site

    Muelheim A.d. Ruhr, 45468

  • Pfizer Investigational Site

    München, 81241

  • Pfizer Investigational Site

    München, 81925

  • Pfizer Investigational Site

    Rosenheim, 83022

Other trials in Germany

Canada11 sites

  • Pfizer Investigational Site

    Calgary, Alberta, T2V 4R6

  • Pfizer Investigational Site

    Edmonton, Alberta, T5H 3V9

  • Pfizer Investigational Site

    Kitchener, Ontario, N2N 2B9

  • Pfizer Investigational Site

    Montreal, Quebec, H2X 1N8

  • Pfizer Investigational Site

    Montreal, Quebec, H2X 3J4

  • Pfizer Investigational Site

    Montreal, Quebec, H3S 1Z1

  • Pfizer Investigational Site

    Saint John, New Brunswick, E2L 3J8

  • Pfizer Investigational Site

    Sherbrooke, Quebec, J1H 5N4

  • Pfizer Investigational Site

    Toronto, Ontario, M4N 3M5

  • Pfizer Investigational Site

    Toronto, Ontario, M6A 3B5

  • Pfizer Investigational Site

    Victoria, British Columbia, V8V 3N1

Other trials in Canada

Brazil7 sites

  • Pfizer Investigational Site

    Campinas, São Paulo, 13084-882

  • Pfizer Investigational Site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Pfizer Investigational Site

    Porto Alegre, Rio Grande do Sul, 90470-340

  • Pfizer Investigational Site

    Rio de Janeiro, Rio de Janeiro, CEP 20551-030

  • Pfizer Investigational Site

    Salvador, Estado de Bahia, 40420-000

  • Pfizer Investigational Site

    São Paulo, São Paulo, 04039-901

  • Pfizer Investigational Site

    São Paulo, São Paulo, 04262-000

Other trials in Brazil

Denmark7 sites

  • Pfizer Investigational Site

    Aalborg, 9100

  • Pfizer Investigational Site

    Aarhus N, 8200

  • Pfizer Investigational Site

    Glostrup Municipality, 2600

  • Pfizer Investigational Site

    Herlev, 2730

  • Pfizer Investigational Site

    Kolding, 6000

  • Pfizer Investigational Site

    Nykoebing Falster, 4800

  • Pfizer Investigational Site

    Roskilde, 4000

Other trials in Denmark

South Africa7 sites

  • Pfizer Investigational Site

    Bloemfontein, Free State, 9300

  • Pfizer Investigational Site

    Cape Town, 8001

  • Pfizer Investigational Site

    Durban, KwaZulu-Natal, 4001

  • Pfizer Investigational Site

    Parktown, Gauteng, 2193

  • Pfizer Investigational Site

    Pietermaritzburg, KwaZulu-Natal, 3201

  • Pfizer Investigational Site

    Pretoria, 0083

  • Pfizer Investigational Site

    Vosloorus, Gauteng, 1475

Other trials in South Africa

India6 sites

  • Pfizer Investigational Site

    Bangalore, Karnataka, 560 034

  • Pfizer Investigational Site

    Hyderabad, Andhra Pradesh, 500 001

  • Pfizer Investigational Site

    Hyderabad, Andhra Pradesh, 500 082

  • Pfizer Investigational Site

    Jaipur, Rajasthan, 302 004

  • Pfizer Investigational Site

    Lucknow, Uttar Pradesh, 226003

  • Pfizer Investigational Site

    Vellore, Tamil Nadu, 632 004

Other trials in India

Norway6 sites

  • Pfizer Investigational Site

    Bergen, 5005

  • Pfizer Investigational Site

    Hamar, 2317

  • Pfizer Investigational Site

    Lysaker, 1366

  • Pfizer Investigational Site

    Oslo, 0264

  • Pfizer Investigational Site

    Oslo, NO-0257

  • Pfizer Investigational Site

    Sandnes, 4313

Other trials in Norway

Russia6 sites

  • Pfizer Investigational Site

    Moscow, Russia, 105425

  • Pfizer Investigational Site

    Moscow, 101000

  • Pfizer Investigational Site

    Moscow, 115516

  • Pfizer Investigational Site

    Moscow, 117815

  • Pfizer Investigational Site

    Rostov-on-Don, 344022

  • Pfizer Investigational Site

    Saint Petersburg, Russia

Other trials in Russia

South Korea6 sites

  • Pfizer Investigational Site

    Daegu, 705-718

  • Pfizer Investigational Site

    Seoul, Korea, 110-744

  • Pfizer Investigational Site

    Seoul, 100-380

  • Pfizer Investigational Site

    Seoul, 120-752

  • Pfizer Investigational Site

    Seoul, 136-705

  • Pfizer Investigational Site

    Seoul, 137-040

Other trials in South Korea

Czechia5 sites

  • Pfizer Investigational Site

    Hradec Králové, 500 02

  • Pfizer Investigational Site

    Jablonec nad Nisou, 466 60

  • Pfizer Investigational Site

    Jindřichův Hradec, 377 38

  • Pfizer Investigational Site

    Ostrava, 708 52

  • Pfizer Investigational Site

    Prague, 180 00

Other trials in Czechia

Poland5 sites

  • Pfizer Investigational Site

    Bialystok, 15-950

  • Pfizer Investigational Site

    Bydgoszcz, 85-168

  • Pfizer Investigational Site

    Lodz, 91-463

  • Pfizer Investigational Site

    Szczecin, 70-11

  • Pfizer Investigational Site

    Warsaw, 02-507

Other trials in Poland

Romania5 sites

  • Pfizer Investigational Site

    Arad, 310175

  • Pfizer Investigational Site

    Bucharest, 041345

  • Pfizer Investigational Site

    Bucharest, 050653

  • Pfizer Investigational Site

    Sibiu, 550245

  • Pfizer Investigational Site

    Timișoara, 300736

Other trials in Romania

Sweden5 sites

  • Pfizer Investigational Site

    Huskvarna, 561 36

  • Pfizer Investigational Site

    Luleå, 97180

  • Pfizer Investigational Site

    Malmö, 205 02

  • Pfizer Investigational Site

    Skövde, 541 30

  • Pfizer Investigational Site

    Stockholm

Other trials in Sweden

Taiwan5 sites

  • Pfizer Investigational Site

    Hualien City, 970

  • Pfizer Investigational Site

    Niao-Sung Hsiang, Kaohsiung, 833

  • Pfizer Investigational Site

    Taichung, 40705

  • Pfizer Investigational Site

    Taipei, 100

  • Pfizer Investigational Site

    Taipei

Other trials in Taiwan

Ukraine5 sites

  • Pfizer Investigational Site

    Chernivtsi, 58002

  • Pfizer Investigational Site

    Kharkiv, 61037

  • Pfizer Investigational Site

    Kyiv, 04053

  • Pfizer Investigational Site

    Odesa, 65000

  • Pfizer Investigational Site

    Zaporizhzhya, 69000

Other trials in Ukraine

Belgium4 sites

  • Pfizer Investigational Site

    Antwerp, 2020

  • Pfizer Investigational Site

    Brussels, 1070

  • Pfizer Investigational Site

    Kortrijk, 8500

  • Pfizer Investigational Site

    Tessenderlo, 3980

Other trials in Belgium

Greece4 sites

  • Pfizer Investigational Site

    Athens, Attica, 10552

  • Pfizer Investigational Site

    Ioannina, Ipiros, 45001

  • Pfizer Investigational Site

    Rio, Patras, 26500

  • Pfizer Investigational Site

    Thessaloniki, 56403

Other trials in Greece

Hungary4 sites

  • Pfizer Investigational Site

    Debrecen, 4026

  • Pfizer Investigational Site

    Nyíregyháza, 4400

  • Pfizer Investigational Site

    Szeged, 6725

  • Pfizer Investigational Site

    Szentes, 6600

Other trials in Hungary

Spain4 sites

  • Pfizer Investigational Site

    Bilbao, Vizcaya, 48013

  • Pfizer Investigational Site

    Getafe, Madrid, 28905

  • Pfizer Investigational Site

    Madrid, Madrid, 28046

  • Pfizer Investigational Site

    Valencia, Valencia, 46010

Other trials in Spain

Chile3 sites

  • Pfizer Investigational Site

    Port Montt, 5480000

  • Pfizer Investigational Site

    Rancagua, Región del Libertador General Bernardo O’Higgins, 2820945

  • Pfizer Investigational Site

    Santiago

Other trials in Chile

Costa Rica3 sites

  • Pfizer Investigational Site

    Alajuela, Alajuela Province

  • Pfizer Investigational Site

    Cartago, Cartago Province

  • Pfizer Investigational Site

    San José, Provincia de San José

Other trials in Costa Rica

Italy3 sites

  • Pfizer Investigational Site

    Latina, 04100

  • Pfizer Investigational Site

    Padova, 35128

  • Pfizer Investigational Site

    Siena, 53100

Other trials in Italy

Colombia2 sites

  • Pfizer Investigational Site

    Bogota, Cundinamarca, 0

  • Pfizer Investigational Site

    Bogota, Cundinamarca

Other trials in Colombia

Hong Kong2 sites

  • Pfizer Investigational Site

    Hong Kong

  • Pfizer Investigational Site

    Shatin

Other trials in Hong Kong

Malaysia2 sites

  • Pfizer Investigational Site

    Batu Caves, Selangor, 68100

  • Pfizer Investigational Site

    Kuala Lumpur, 59100

Other trials in Malaysia

Peru2 sites

  • Pfizer Investigational Site

    Lima, Lima Province, L27

  • Pfizer Investigational Site

    Surco, Lima region, L33

Other trials in Peru

Singapore2 sites

  • Pfizer Investigational Site

    Singapore, Singapore, 119074

  • Pfizer Investigational Site

    Singapore, Singapore, 229899

Other trials in Singapore

Switzerland2 sites

  • Pfizer Investigational Site

    Frauenfeld, CH-8500

  • Pfizer Investigational Site

    Lucerne, CH-6000

Other trials in Switzerland

About this study

Official title: 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

Being tested
fesoterodine fumarate, placebo, tolterodine tartrate
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fesoterodine fumarateDrug

    4 mg once daily (OD) for 1 week followed by a forced dose-escalation to 8 mg once daily (OD) for 11 weeks

  • placeboDrug

    once daily (OD)for 12 weeks

  • tolterodine tartrateDrug

    4 mg once daily (OD) for 12 weeks

Study groups in NCT00444925
Study groupRoleWhat they receive
FesoterodineExperimentalTablets
Receives: Drug: fesoterodine fumarate
PlaceboPlacebo comparatorTablets and capsules
Receives: Drug: placebo
TolterodineActive comparatorCapsules
Receives: Drug: tolterodine tartrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (End of Treatment).

    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.

    Measured: Baseline, Week 12

Secondary outcomes (17)

  1. Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 1 and 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.

    Measured: Baseline, Week 1, Week 4

  2. Percent Change From Baseline of UUI Episodes Per 24 Hours.

    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.

    Measured: Baseline, Week 1, Week 4, Week 12

  3. Change From Baseline in Mean Voided Volume Per Micturition.

    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.

    Measured: Baseline, Week 1, Week 4, Week 12

  4. Change From Baseline in Mean Number of Micturitions Per 24 Hours.

    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.

    Measured: Baseline, Week 1, Week 4, Week 12

  5. Percent Change From Baseline of Micturitions Per 24 Hours.

    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).

    Measured: Baseline, Week 1, Week 4, Week 12

  6. Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours.

    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.

    Measured: Baseline, Week 1, Week 4, Week 12

  7. Percent Change From Baseline of Nocturnal Micturitions Per 24 Hours.

    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.

    Measured: Baseline, Week 1, Week 4, Week 12

  8. Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours.

    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.

    Measured: Baseline, Week 1, Week 4, Week 12

  9. Percent Change From Baseline of Urgency Episodes Per 24 Hours.

    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).

    Measured: Baseline, Week 1, Week 4, Week 12

  10. Change From Baseline in Mean Number of Severe Urgency Episodes Per 24 Hours.

    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.

    Measured: Baseline, Week 1, Week 4, Week 12

  11. Percent Change From Baseline of Severe Urgency Episodes Per 24 Hours.

    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).

    Measured: Baseline, Week 1, Week 4, Week 12

  12. Change From Baseline in Mean USS Rating Per Micturition Per 24 Hours.

    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.

    Measured: Baseline, Week 1, Week 4, Week 12

  13. Change From Baseline in Frequency-Urgency Sum (Formerly Known as Urinary Sensations Scale Sum in Protocol) Per 24 Hours.

    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.

    Measured: Baseline, Week 1, Week 4, Week 12

  14. Change From Baseline in Patient Perception of Bladder Condition (PPBC).

    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.

    Measured: Baseline, Week 1, Week, 4, Week 12

  15. Change From Baseline in Urgency Perception Scale (UPS). UPS Equals Patient Perception of Urgency Scale (PPUS) in Protocol.

    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.

    Measured: Baseline, Week 1, Week 4, Week 12

  16. Change From Baseline in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score at Week 12 (End of Treatment).

    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.

    Measured: Baseline, Week 12

  17. Change From Baseline in OAB-q: Health Related Quality of Life (HRQL) at Week 12 (End of Treatment).

    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.

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,712 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00444925
Sponsor's protocol ID
A0221008
Status last verified
Mar 2015
First submitted
6 Mar 2007
Last updated
24 Mar 2015
Data monitoring committee
No

Publications

  • Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

    PubMed 37160401

  • Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.

    PubMed 35881009

  • Corcos J, Angulo JC, Garely AD, Carlsson M, Gong J, Guan Z; Fesoterodine Assessment and Comparison Versus Tolterodine (FACT) Study Group. Effect of fesoterodine 4 mg on bladder diary and patient-reported outcomes during the first week of treatment in subjects with overactive bladder. Curr Med Res Opin. 2011 May;27(5):1059-65. doi: 10.1185/03007995.2011.565044. Epub 2011 Mar 23.

    PubMed 21428726

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fesoterodine fumarate and tolterodine tartrate in people with Overactive Bladder, run by Pfizer at 178 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 sites in United States, Germany, Canada, Brazil, Denmark and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00444925, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in