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Detrol LA In Men With Overactive Bladder.

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Overactive Bladder (OAB)

Intervention: Detrol LA (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

An interventional active/placebo double blinded parallel randomized controlled study in which at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is measured along with associated safety and other secondary endpoints like bladder diary endpoints, quality of life and patient treatment satisfaction. Patients included in the study must have symptoms of OAB (frequency of at least 8 per day and Urgency of at least 1 episode per day confirmed by bladder diary). Patients are not eligible to enroll in the study if they have/had significant hepatic or renal disease, history of radiation treatment.

Clinical Details

Official title: A Randomized, Double Blind, Placebo Controlled Detrol LA "Add-On" To Alpha-Blocker Study In Men With Persistent Overactive Bladder Symptoms Of Urinary Frequency And Urgency With/Without Urgency Incontinence After Previous Monotherapy With Alpha Blocker.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Patient Perception of Bladder Condition at 12 weeks of treatment

Secondary outcome:

1)To evaluate the additional benefit of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence: a)On OAB symptoms as

assessed by 5-day voiding bladder diaries including Urinary Sensation Scale, b)On symptoms as assessed by the International Prostate Symptom Score (IPSS), c)On patient perception of treatment benefit as assessed by the Patient Perception of Treatment

Benefit Questionnaire (PPTB) , d)On patient perception of bladder condition as assessed by the change in the PPBC after 4 weeks of treatment, e)On bothersome quality of life (QoL) symptoms as assessed by the Overactive Bladder Questionnaire (OAB-q),

f)On sexual QoL as assessed by the ICIQ-MLUTSsex Questionnaire , g)On patient satisfaction with medication as assessed by the Overactive Bladder Treatment Satisfaction Questionnaires (OAB-s), h)On nocturia bothersome measure as assessed by the Nocturia

Quality-of-Life Questionnaire, 2)To evaluate the safety and tolerability of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency

incontinence.

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Symptoms of OAB (frequency more than 8 per day and Urgency more than 1 episode per

day confirmed by bladder diary) Exclusion Criteria:

- Significant hepatic or renal disease, history of radiation treatment

Locations and Contacts

Pfizer Investigational Site, Aalborg 9100, Denmark

Pfizer Investigational Site, Herlev DK-2730, Denmark

Pfizer Investigational Site, Nykobing Falster 4800, Denmark

Pfizer Investigational Site, Berlin 13347, Germany

Pfizer Investigational Site, Duisburg 47179, Germany

Pfizer Investigational Site, Frankfurt 65929, Germany

Pfizer Investigational Site, Muelheim a.d. Ruhr 45468, Germany

Pfizer Investigational Site, Muenchen 81369, Germany

Pfizer Investigational Site, Muenchen 81925, Germany

Pfizer Investigational Site, Rosenheim 83022, Germany

Pfizer Investigational Site, Starnberg 82319, Germany

Pfizer Investigational Site, Latina 04100, Italy

Pfizer Investigational Site, Padova 35128, Italy

Pfizer Investigational Site, Busan 602-739, Korea, Republic of

Pfizer Investigational Site, Seoul 135-270, Korea, Republic of

Pfizer Investigational Site, Seoul 138-736, Korea, Republic of

Pfizer Investigational Site, Durango 34000, Mexico

Pfizer Investigational Site, Durango 34079, Mexico

Pfizer Investigational Site, Bodø 8087, Norway

Pfizer Investigational Site, Moelv 2391, Norway

Pfizer Investigational Site, Bratislava 833 05, Slovakia

Pfizer Investigational Site, Kosice 040 11, Slovakia

Pfizer Investigational Site, Malacky 901 01, Slovakia

Pfizer Investigational Site, Martin 036 01, Slovakia

Pfizer Investigational Site, Skalica 909 82, Slovakia

Pfizer Investigational Site, Cape Town 8001, South Africa

Pfizer Investigational Site, Barcelona 08025, Spain

Pfizer Investigational Site, Granada 18014, Spain

Pfizer Investigational Site, Madrid 28016, Spain

Pfizer Investigational Site, Madrid 28040, Spain

Pfizer Investigational Site, Valencia 46009, Spain

Pfizer Investigational Site, Boras 503 32, Sweden

Pfizer Investigational Site, Huskvarna 561 36, Sweden

Pfizer Investigational Site, Lund 221 85, Sweden

Pfizer Investigational Site, Skovde 541 30, Sweden

Pfizer Investigational Site, Hualien 970, Taiwan

Pfizer Investigational Site, Kaohsiung 833, Taiwan

Pfizer Investigational Site, Taipei 100, Taiwan

Pfizer Investigational Site, Taipei, Taiwan

Pfizer Investigational Site, Adana 01230, Turkey

Pfizer Investigational Site, Istanbul, Turkey

Pfizer Investigational Site, Izmir 35100, Turkey

Pfizer Investigational Site, Sihhiye-Ankara, Turkey

Pfizer Investigational Site, London N19 5LW, United Kingdom

Pfizer Investigational Site, A Coruna, A Coruña 15006, Spain

Pfizer Investigational Site, Calgary, Alberta T2V 4R6, Canada

Pfizer Investigational Site, Bristol, Avon BS10 5NB, United Kingdom

Pfizer Investigational Site, Surrey, British Columbia V3V 1N1, Canada

Pfizer Investigational Site, Victoria, British Columbia V8T5G1, Canada

Pfizer Investigational Site, Anaheim, California 92801, United States

Pfizer Investigational Site, La Mesa, California 91942, United States

Pfizer Investigational Site, Crewe, Cheshire CW1 4QJ, United Kingdom

Pfizer Investigational Site, Aurora, Colorado 80012, United States

Pfizer Investigational Site, Bloemfontein, Free State 9300, South Africa

Pfizer Investigational Site, Bloemfontein, Free State 9301, South Africa

Pfizer Investigational Site, Parktown, Gauteng Province 2193, South Africa

Pfizer Investigational Site, Bucheon-si, Gyunggi-do 420-717, Korea, Republic of

Pfizer Investigational Site, Iowa City, Iowa 52242-1089, United States

Pfizer Investigational Site, Palma de Mallorca, Islas Baleares 07014, Spain

Pfizer Investigational Site, Guadalajara, Jalisco 44100, Mexico

Pfizer Investigational Site, Zapopan, Jalisco 45200, Mexico

Pfizer Investigational Site, Durban, Kwa Zulu Natal 4001, South Africa

Pfizer Investigational Site, Pietermaritzburg, Kwa Zulu Natal 3201, South Africa

Pfizer Investigational Site, Shreveport, Louisiana 71106, United States

Pfizer Investigational Site, Watertown, Massachusetts 02472, United States

Pfizer Investigational Site, Tlalpan, México DF 14000, Mexico

Pfizer Investigational Site, Westampton, New Jersey 08060, United States

Pfizer Investigational Site, New York, New York 10016, United States

Pfizer Investigational Site, Cincinnati, Ohio 45212, United States

Pfizer Investigational Site, Kingston, Ontario K7L 3J7, Canada

Pfizer Investigational Site, London, Ontario N6A 4V2, Canada

Pfizer Investigational Site, Oakville, Ontario L6H 3P1, Canada

Pfizer Investigational Site, Toronto, Ontario M4N 3M5, Canada

Pfizer Investigational Site, Toronto, Ontario M5T 2S8, Canada

Pfizer Investigational Site, Toronto, Ontario M6A 3B5, Canada

Pfizer Investigational Site, State College, Pennsylvania 16801, United States

Pfizer Investigational Site, Montreal, Quebec H3S 1Z1, Canada

Pfizer Investigational Site, Montreal, Quebec H2X 1N8, Canada

Pfizer Investigational Site, Pointe-Claire, Quebec H9R 4S3, Canada

Pfizer Investigational Site, Taunton, Somerset TA1 5DA, United Kingdom

Pfizer Investigational Site, Houston, Texas 77024, United States

Additional Information

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

Starting date: January 2006
Last updated: September 5, 2007

Page last updated: August 23, 2015

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