Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction

NCT00147654

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, , United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Urinary Incontinence
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

- Male 40 years of age

- Clinical signs and symptoms of frequency and urgency, with or without UUI, with or without BOO, for at least three months

- Mean urinary frequency of 8 micturitions/24h verified by the Screening micturition diary

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


- Post-void residual urine volume (PVR) of > 200 ml as measured by an ultrasound


- Maximum urinary flow rate (Qmax) of < 5 ml/second as measured by a flowmeter; a voided
volume of 75 ml is required in order to accurately record the Qmax


- Prescribed and administered an antimuscarinic or antispasmodic within 1 month


- Prescribed and administered an a-1-adrenergic antagonist within 2 weeks

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Advanced Information
Descriptive Information
Brief Title  ICMJE Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction
Official Title  ICMJE A Randomized, Double Blind, Placebo Controlled, Four Arm (Placebo, Tolterodine ER, Tamsulosin, and Tolterodine ER Plus Tamsulosin) Study To Evaluate The Clinical Efficacy And Safety Of Tolterodine ER 4 mg In Men Who Have Frequency and Urgency, With Or Without Urinary Urge Incontinence, With Or Without Bladder Outlet Obstruction
Brief Summary The primary objective of the trial is to evaluate the effect of tolterodine ER plus tamsulosin versus placebo on patient perception of overall treatment benefit in men who have frequency and urgency, with or without urinary urge incontinence (UUI), with or without bladder outlet obstruction (BOO).
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 Urinary Incontinence
Intervention  ICMJE
  • Drug: Tolterodine ER 4 mg QD
  • Drug: Tamsulosin 0.4 mg QD
Study Arms  ICMJE Not Provided
Publications * Kaplan SA, Roehrborn CG, Rovner ES, Carlsson M, Bavendam T, Guan Z. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2319-28. Erratum in: JAMA. 2007 Mar 21:297(11):1195. JAMA. 2007 Oct 24;298(16):1864.

*   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: September 2, 2005)
830
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male 40 years of age
  • Clinical signs and symptoms of frequency and urgency, with or without UUI, with or without BOO, for at least three months
  • Mean urinary frequency of 8 micturitions/24h verified by the Screening micturition diary

Exclusion Criteria:

  • Post-void residual urine volume (PVR) of > 200 ml as measured by an ultrasound
  • Maximum urinary flow rate (Qmax) of < 5 ml/second as measured by a flowmeter; a voided volume of 75 ml is required in order to accurately record the Qmax
  • Prescribed and administered an antimuscarinic or antispasmodic within 1 month
  • Prescribed and administered an a-1-adrenergic antagonist within 2 weeks
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00147654
Other Study ID Numbers  ICMJE A6121120
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 CenterPfizer
PRS Account Pfizer
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP