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Trial record 1 of 1 for:    NCT00645281
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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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ClinicalTrials.gov Identifier: NCT00645281
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 27, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 25, 2008
First Posted Date  ICMJE March 27, 2008
Last Update Posted Date March 27, 2008
Study Start Date  ICMJE March 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2008)
Change from baseline to Week 12 in the micturition bladder diary variable related to the primary symptom of the patient at the time of study entry [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2008)
  • OAB Bother Rating Scale at baseline [ Time Frame: baseline ]
  • Change from baseline to Week 4 and 12 in micturition bladder diary variables [ Time Frame: 12 weeks ]
  • Change from baseline to Week 4 and 12 in Patient's Perception of Bladder Condition [ Time Frame: 12 weeks ]
  • Change from baseline to Week 4 and 12 in AUA Symptom Index [ Time Frame: 12 weeks ]
  • Change from baseline to Week 4 and 12 in OAB questionnaire [ Time Frame: 12 weeks ]
  • Clinical Global Impression-Improvement at Week 12 [ Time Frame: 12 weeks ]
  • Overall Treatment Effect Scale of Overactive Bladder Control at Week 4 and 12 [ Time Frame: 12 weeks ]
  • To asses the safety of tolterodine in patients with OAB [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Summary 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.
Detailed Description Not 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 Date Not 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 Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2008

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