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Detrol LA In Men With Overactive Bladder.

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NCT00282932

Last updated on January 24, 2020
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Study Location
Pfizer Investigational Site
Anaheim, California, 92801 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder (OAB)
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Symptoms of OAB (frequency more than 8 per day and Urgency more than 1 episode per day
confirmed by bladder diary)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Significant hepatic or renal disease, history of radiation treatment

NCT00282932
Pfizer
Completed
Detrol LA In Men With Overactive Bladder.

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Descriptive Information
Brief Title  ICMJE Detrol LA In Men With Overactive Bladder.
Official Title  ICMJE 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.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder (OAB)
Intervention  ICMJE Drug: Detrol LA
Study Arms  ICMJE Not Provided
Publications * Chapple C, Herschorn S, Abrams P, Sun F, Brodsky M, Guan Z. Tolterodine treatment improves storage symptoms suggestive of overactive bladder in men treated with alpha-blockers. Eur Urol. 2009 Sep;56(3):534-41. doi: 10.1016/j.eururo.2008.11.026. Epub 2008 Nov 24.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 26, 2006) 		600
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 14, 2007
Actual Primary Completion Date May 1, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   Germany,   Italy,   Korea, Republic of,   Mexico,   Norway,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00282932
Other Study ID Numbers  ICMJE A6121127
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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