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A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.

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NCT00645281

Last updated on November 21, 2019
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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35211 United States
See other locations
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 Urinary Bladder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- self-reported symptoms of OAB for ≥ 3 months prior to screening

- OAB as defined by urinary frequency (a minimum of 8 micturitions per 24 hours)

- urgency (defined as a strong and sudden desire to urinate) or urge incontinence a
minimum of 2 episodes in 3 days, as confirmed by the micturition diary between
screening and baseline

- patients who describe the degree of bothersomeness of their most bothersome OAB
symptom as "moderately ", "a great deal ", or "a very great deal" per the OAB Bother
Rating Scale

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

- any condition that would contraindicate their usage of tolterodine once daily,
including: narrow angle glaucoma, urinary retention, gastric retention

- any clinically significant local urinary tract pathology which could mimic the
symptoms of OAB, such as infection or hematuria

- stress incontinence, functional, or overflow incontinence as determined by the
investigator

- symptomatic acute urinary tract infection (UTI) during the run-in period, or
recurrent UTIs defined by treatment for symptomatic UTI >3 times in the 12 months
prior to participation in this clinical trial

- clinically significant urinary tract obstruction

- history of lower urinary tract surgery (e.g. prostate removal or destruction,
incontinence surgery) within the past 3 months

- clinically significant interstitial cystitis or significant bladder pain syndrome

NCT00645281
Pfizer
Completed
A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.

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Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.
Official Title  ICMJE Symptom Specific Effectiveness of Tolterodine ER 4 mg in Patients With Symptoms of Overactive Bladder (OAB) in a Primary Care Setting. A Phase IV, Open-Label, Single-Arm, Non-Randomized, Trial in Adult Patients With OAB.
Brief SummaryThe purpose of this study is to evaluate the efficacy and safety of tolterodine in impacting the primary symptom or complaint of patients with OAB.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Bladder, Overactive
Intervention  ICMJE Drug: tolterodine extended release
Tolterodine ER capsule 4 mg daily for 12 weeks
Study Arms  ICMJE Experimental: tolterodine ER group
Intervention: Drug: tolterodine extended release
Publications *Not Provided


*   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
Actual Enrollment  ICMJE
 (submitted: March 25, 2008)		896
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2005
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • self-reported symptoms of OAB for ? 3 months prior to screening
  • OAB as defined by urinary frequency (a minimum of 8 micturitions per 24 hours)
  • urgency (defined as a strong and sudden desire to urinate) or urge incontinence a minimum of 2 episodes in 3 days, as confirmed by the micturition diary between screening and baseline
  • patients who describe the degree of bothersomeness of their most bothersome OAB symptom as "moderately ", "a great deal ", or "a very great deal" per the OAB Bother Rating Scale

Exclusion Criteria:

  • any condition that would contraindicate their usage of tolterodine once daily, including: narrow angle glaucoma, urinary retention, gastric retention
  • any clinically significant local urinary tract pathology which could mimic the symptoms of OAB, such as infection or hematuria
  • stress incontinence, functional, or overflow incontinence as determined by the investigator
  • symptomatic acute urinary tract infection (UTI) during the run-in period, or recurrent UTIs defined by treatment for symptomatic UTI >3 times in the 12 months prior to participation in this clinical trial
  • clinically significant urinary tract obstruction
  • history of lower urinary tract surgery (e.g. prostate removal or destruction, incontinence surgery) within the past 3 months
  • clinically significant interstitial cystitis or significant bladder pain syndrome
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 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 NCT00645281
Other Study ID Numbers  ICMJE A6121001
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2008

ICMJE     Data element required by the

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

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