Detrol LA In Men With Overactive Bladder.

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

600

Phase

  • Phase 4

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2V 4R6
        • Pfizer Investigational Site
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1N1
        • Pfizer Investigational Site
      • Victoria, British Columbia, Canada, V8T5G1
        • Pfizer Investigational Site
    • Ontario
      • Kingston, Ontario, Canada, K7L 3J7
        • Pfizer Investigational Site
      • London, Ontario, Canada, N6A 4V2
        • Pfizer Investigational Site
      • Oakville, Ontario, Canada, L6H 3P1
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M6A 3B5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5T 2S8
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 1N8
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3S 1Z1
        • Pfizer Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Pfizer Investigational Site
  • Denmark
      • Aalborg, Denmark, 9100
        • Pfizer Investigational Site
      • Herlev, Denmark, DK-2730
        • Pfizer Investigational Site
      • Nykobing Falster, Denmark, 4800
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 13347
        • Pfizer Investigational Site
      • Duisburg, Germany, 47179
        • Pfizer Investigational Site
      • Frankfurt, Germany, 65929
        • Pfizer Investigational Site
      • Muelheim A.d. Ruhr, Germany, 45468
        • Pfizer Investigational Site
      • Muenchen, Germany, 81925
        • Pfizer Investigational Site
      • Muenchen, Germany, 81369
        • Pfizer Investigational Site
      • Rosenheim, Germany, 83022
        • Pfizer Investigational Site
      • Starnberg, Germany, 82319
        • Pfizer Investigational Site
  • Italy
      • Latina, Italy, 04100
        • Pfizer Investigational Site
      • Padova, Italy, 35128
        • Pfizer Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-270
        • Pfizer Investigational Site
    • Gyunggi-do
      • Bucheon-si, Gyunggi-do, Korea, Republic of, 420-717
        • Pfizer Investigational Site
  • Mexico
      • Durango, Mexico, 34000
        • Pfizer Investigational Site
      • Durango, Mexico, 34079
        • Pfizer Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44100
        • Pfizer Investigational Site
      • Zapopan, Jalisco, Mexico, 45200
        • Pfizer Investigational Site
    • México DF
      • Tlalpan, México DF, Mexico, 14000
        • Pfizer Investigational Site
  • Norway
      • Bodø, Norway, 8087
        • Pfizer Investigational Site
      • Moelv, Norway, 2391
        • Pfizer Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 833 05
        • Pfizer Investigational Site
      • Kosice, Slovakia, 040 11
        • Pfizer Investigational Site
      • Malacky, Slovakia, 901 01
        • Pfizer Investigational Site
      • Martin, Slovakia, 036 01
        • Pfizer Investigational Site
      • Skalica, Slovakia, 909 82
        • Pfizer Investigational Site
  • South Africa
      • Cape Town, South Africa, 8001
        • Pfizer Investigational Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9300
        • Pfizer Investigational Site
      • Bloemfontein, Free State, South Africa, 9301
        • 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
      • Barcelona, Spain, 08025
        • Pfizer Investigational Site
      • Granada, Spain, 18014
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
      • Madrid, Spain, 28016
        • Pfizer Investigational Site
      • Valencia, Spain, 46009
        • Pfizer Investigational Site
    • A Coruña
      • A Coruna, A Coruña, Spain, 15006
        • Pfizer Investigational Site
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07014
        • Pfizer Investigational Site
  • Sweden
      • Boras, Sweden, 503 32
        • Pfizer Investigational Site
      • Huskvarna, Sweden, 561 36
        • Pfizer Investigational Site
      • Lund, Sweden, 221 85
        • Pfizer Investigational Site
      • Skovde, Sweden, 541 30
        • Pfizer Investigational Site
  • Taiwan
      • Hualien, Taiwan, 970
        • Pfizer Investigational Site
      • Kaohsiung, Taiwan, 833
        • Pfizer Investigational Site
      • Taipei, Taiwan, 100
        • Pfizer Investigational Site
      • Taipei, Taiwan
        • Pfizer Investigational Site
  • Turkey
      • Adana, Turkey, 01230
        • Pfizer Investigational Site
      • Istanbul, Turkey
        • Pfizer Investigational Site
      • Izmir, Turkey, 35100
        • Pfizer Investigational Site
      • Sihhiye-Ankara, Turkey
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, N19 5LW
        • Pfizer Investigational Site
    • Avon
      • Bristol, Avon, United Kingdom, BS10 5NB
        • Pfizer Investigational Site
    • Cheshire
      • Crewe, Cheshire, United Kingdom, CW1 4QJ
        • Pfizer Investigational Site
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA
        • Pfizer Investigational Site
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Pfizer Investigational Site
      • La Mesa, California, United States, 91942
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Pfizer Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242-1089
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Pfizer Investigational Site
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
        • Pfizer Investigational Site
    • New Jersey
      • Westampton, New Jersey, United States, 08060
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10016
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Pfizer Investigational Site
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77024
        • 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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Patient Perception of Bladder Condition at 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

January 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 14, 2007

Study Registration Dates

First Submitted

January 26, 2006

First Submitted That Met QC Criteria

January 26, 2006

First Posted (Estimate)

January 27, 2006

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6121127

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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