You are here

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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35211 United States
Contact
1-800-718-1021
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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.
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.
The purpose of this study is to evaluate the efficacy and safety of tolterodine in impacting the primary symptom or complaint of patients with OAB.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Urinary Bladder, Overactive
Drug: tolterodine extended release
Tolterodine ER capsule 4 mg daily for 12 weeks
Experimental: tolterodine ER group
Intervention: Drug: tolterodine extended release
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
896
January 2005
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00645281
A6121001
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now