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

Overactive Bladder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444925
• Other study ID #: A0221008
• Status: Completed
• Phase: Phase 3
• First received: March 6, 2007
• Last updated: March 4, 2015
• Start date: April 2007
• Est. completion date: July 2008

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1712
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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
once daily (OD)for 12 weeks
• tolterodine tartrate
4 mg once daily (OD) for 12 weeks

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Antwerpen
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Kortrijk
Belgium	Pfizer Investigational Site	Tessenderlo
Brazil	Pfizer Investigational Site	Campinas	SP
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Salvador	BA
Brazil	Pfizer Investigational Site	São Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo	SP
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Kitchener	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montréal	Quebec
Canada	Pfizer Investigational Site	Saint John	New Brunswick
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Victoria	British Columbia
Chile	Pfizer Investigational Site	Puerto Montt
Chile	Pfizer Investigational Site	Rancagua	VI Región
Chile	Pfizer Investigational Site	Santiago
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Costa Rica	Pfizer Investigational Site	Alajuela
Costa Rica	Pfizer Investigational Site	Cartago
Costa Rica	Pfizer Investigational Site	San Jose
Czech Republic	Pfizer Investigational Site	Hradec Kralove
Czech Republic	Pfizer Investigational Site	Jablonec nad Nisou
Czech Republic	Pfizer Investigational Site	Jindrichuv Hradec
Czech Republic	Pfizer Investigational Site	Ostrava
Czech Republic	Pfizer Investigational Site	Praha 8
Denmark	Pfizer Investigational Site	Aalborg
Denmark	Pfizer Investigational Site	Aarhus N
Denmark	Pfizer Investigational Site	Glostrup
Denmark	Pfizer Investigational Site	Herlev
Denmark	Pfizer Investigational Site	Kolding
Denmark	Pfizer Investigational Site	Nykoebing Falster
Denmark	Pfizer Investigational Site	Roskilde
Germany	Pfizer Investigational Site	Ahaus
Germany	Pfizer Investigational Site	Alzey
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Karlsruhe
Germany	Pfizer Investigational Site	Krumbach
Germany	Pfizer Investigational Site	Leipzig
Germany	Pfizer Investigational Site	Leipzig
Germany	Pfizer Investigational Site	Marburg
Germany	Pfizer Investigational Site	Muelheim a.d. Ruhr
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Rosenheim
Greece	Pfizer Investigational Site	Athens	Attiki
Greece	Pfizer Investigational Site	Ioannina	Ipiros
Greece	Pfizer Investigational Site	Rio, Patras
Greece	Pfizer Investigational Site	Thessaloniki
Hong Kong	Pfizer Investigational Site	Hong Kong
Hong Kong	Pfizer Investigational Site	Shatin
Hungary	Pfizer Investigational Site	Debrecen
Hungary	Pfizer Investigational Site	Nyiregyhaza
Hungary	Pfizer Investigational Site	Szeged
Hungary	Pfizer Investigational Site	Szentes
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Hyderabad	Andhra Pradesh
India	Pfizer Investigational Site	Hyderabad	Andhra Pradesh
India	Pfizer Investigational Site	Jaipur	Rajasthan
India	Pfizer Investigational Site	Lucknow	Uttar Pradesh
India	Pfizer Investigational Site	Vellore	Tamil Nadu
Italy	Pfizer Investigational Site	Latina
Italy	Pfizer Investigational Site	Padova
Italy	Pfizer Investigational Site	Siena
Korea, Republic of	Pfizer Investigational Site	Daegu
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul	Korea
Malaysia	Pfizer Investigational Site	Batu Caves	Selangor
Malaysia	Pfizer Investigational Site	Kuala Lumpur
Norway	Pfizer Investigational Site	Bergen
Norway	Pfizer Investigational Site	Hamar
Norway	Pfizer Investigational Site	Lysaker
Norway	Pfizer Investigational Site	Oslo
Norway	Pfizer Investigational Site	Oslo
Norway	Pfizer Investigational Site	Sandnes
Peru	Pfizer Investigational Site	Lima
Peru	Pfizer Investigational Site	Surco	Lima
Poland	Pfizer Investigational Site	Bialystok
Poland	Pfizer Investigational Site	Bydgoszcz
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Szczecin
Poland	Pfizer Investigational Site	Warszawa
Romania	Pfizer Investigational Site	Arad
Romania	Pfizer Investigational Site	Bucuresti
Romania	Pfizer Investigational Site	Bucuresti
Romania	Pfizer Investigational Site	Sibiu
Romania	Pfizer Investigational Site	Timisoara
Russian Federation	Pfizer Investigational Site	Moscow	Russia
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Rostov-on-Don
Russian Federation	Pfizer Investigational Site	St. Petersburg	Russia
Singapore	Pfizer Investigational Site	Singapore
Singapore	Pfizer Investigational Site	Singapore
South Africa	Pfizer Investigational Site	Bloemfontein	Free State
South Africa	Pfizer Investigational Site	Cape Town
South Africa	Pfizer Investigational Site	Durban	Kwa Zulu Natal
South Africa	Pfizer Investigational Site	Parktown	Gauteng Province
South Africa	Pfizer Investigational Site	Pietermaritzburg	Kwa Zulu Natal
South Africa	Pfizer Investigational Site	Pretoria
South Africa	Pfizer Investigational Site	Vosloorus	Gauteng
Spain	Pfizer Investigational Site	Bilbao	Vizcaya
Spain	Pfizer Investigational Site	Getafe	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Valencia
Sweden	Pfizer Investigational Site	Huskvarna
Sweden	Pfizer Investigational Site	Lulea
Sweden	Pfizer Investigational Site	Malmo
Sweden	Pfizer Investigational Site	Skovde
Sweden	Pfizer Investigational Site	Stockholm
Switzerland	Pfizer Investigational Site	Frauenfeld
Switzerland	Pfizer Investigational Site	Luzern 16
Taiwan	Pfizer Investigational Site	Hualien
Taiwan	Pfizer Investigational Site	Niao-Sung Hsiang	Kaohsiung
Taiwan	Pfizer Investigational Site	Taichung City
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
Ukraine	Pfizer Investigational Site	Chernivtsi
Ukraine	Pfizer Investigational Site	Kharkiv
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Odessa
Ukraine	Pfizer Investigational Site	Zaporizhzhia
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Allentown	Pennsylvania
United States	Pfizer Investigational Site	Allentown	Pennsylvania
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Aurora	Illinois
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Burlington	North Carolina
United States	Pfizer Investigational Site	Carmichael	California
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Chaska	Minnesota
United States	Pfizer Investigational Site	Chesapeake	Virginia
United States	Pfizer Investigational Site	Coeur D Alene	Idaho
United States	Pfizer Investigational Site	Columbia	South Carolina
United States	Pfizer Investigational Site	Concord	North Carolina
United States	Pfizer Investigational Site	Dayton	Ohio
United States	Pfizer Investigational Site	East Providence	Rhode Island
United States	Pfizer Investigational Site	Garden City	New York
United States	Pfizer Investigational Site	Homewood	Alabama
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Huntersville	North Carolina
United States	Pfizer Investigational Site	Huntsville	Alabama
United States	Pfizer Investigational Site	Kingsport	Tennessee
United States	Pfizer Investigational Site	Lawrenceville	New Jersey
United States	Pfizer Investigational Site	Menomonee Falls	Wisconsin
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Milan	Tennessee
United States	Pfizer Investigational Site	Mineola	New York
United States	Pfizer Investigational Site	Mobile	Alabama
United States	Pfizer Investigational Site	Newton	Kansas
United States	Pfizer Investigational Site	Orangevale	California
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Provo	Utah
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Sandpoint	Idaho
United States	Pfizer Investigational Site	Seattle	Washington
United States	Pfizer Investigational Site	Shrevport	Louisiana
United States	Pfizer Investigational Site	Waterbury	Connecticut
United States	Pfizer Investigational Site	Watertown	Massachusetts
United States	Pfizer Investigational Site	Wellington	Florida
United States	Pfizer Investigational Site	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  Chile,  Colombia,  Costa Rica,  Czech Republic,  Denmark,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Italy,  Korea, Republic of,  Malaysia,  Norway,  Peru,  Poland,  Romania,  Russian Federation,  Singapore,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 12	No
Secondary	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.	Baseline, Week 1, Week 4	No
Secondary	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.	Baseline, Week 1, Week 4, Week 12	No
Secondary	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.	Baseline, Week 1, Week 4, Week 12	No
Secondary	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.	Baseline, Week 1, Week 4, Week 12	No
Secondary	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).	Baseline, Week 1, Week 4, Week 12	No
Secondary	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.	Baseline, Week 1, Week 4, Week 12	No
Secondary	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.	Baseline, Week 1, Week 4, Week 12	No
Secondary	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.	Baseline, Week 1, Week 4, Week 12	No
Secondary	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).	Baseline, Week 1, Week 4, Week 12	No
Secondary	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.	Baseline, Week 1, Week 4, Week 12	No
Secondary	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).	Baseline, Week 1, Week 4, Week 12	No
Secondary	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.	Baseline, Week 1, Week 4, Week 12	No
Secondary	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.	Baseline, Week 1, Week 4, Week 12	No
Secondary	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.	Baseline, Week 1, Week, 4, Week 12	No
Secondary	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.	Baseline, Week 1, Week 4, Week 12	No
Secondary	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.	Baseline, Week 12	No
Secondary	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.	Baseline, Week 12	No

External Links

•   To obtain contact information for a study center near you, click here.