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Trial record 1 of 1 for:    NCT00746681
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Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder

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ClinicalTrials.gov Identifier: NCT00746681
Recruitment Status : Completed
First Posted : September 4, 2008
Last Update Posted : December 21, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE April 2, 2008
First Posted Date  ICMJE September 4, 2008
Last Update Posted Date December 21, 2009
Study Start Date  ICMJE December 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
Change in mean voided volume per micturition (from baseline). [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
  • Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline). [ Time Frame: 4 Weeks ]
  • Percentage and absolute change in urgency episode frequency [ Time Frame: 4 Weeks ]
  • Mean severity of urgency episodes [ Time Frame: 4 Weeks ]
  • Percentage and absolute change in micturition frequency [ Time Frame: 4 Weeks ]
  • Percentage and absolute change in normalized micturition frequency (NMF) [ Time Frame: 4 Weeks ]
  • Patient perception of their urinary urgency (using the OAB-q symptom severity scale) [ Time Frame: 4 Weeks ]
  • Patient perception of Health Related Quality of Life (using the OAB-q SF HRQL scale) [ Time Frame: 4 Weeks ]
  • Patient Perception of Bladder Condition (PPBC) scale [ Time Frame: 4 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 Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder
Official Title  ICMJE A Phase 2, 26 Week, Multicentre, Randomized Double Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Tolterodine, Pregabalin and a Tolterodine-Pregabalin Combination for Idiopathic Overactive Bladder
Brief Summary Tolterodine is approved for use in the treatment of overactive bladder (OAB). The study is designed to a investigate whether pregabalin may have efficacy in OAB and whether the efficacy is altered when it is combined with tolterodine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder
Intervention  ICMJE
  • Drug: Tolterodine & Pregabalin
    Tolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks
  • Drug: Tolterodine
    Tolterodine SR, Oral, 4 mg, once daily for 4 weeks
  • Drug: Placebo
    Placebo, Oral, twice daily for 4 weeks
  • Drug: Tolterodine & Pregabalin
    Tolterodine SR Oral, 4mg, once daily for 4 weeks Pregabalin, Oral, 150 mg, twice daily for 4 weeks
  • Drug: Pregabalin
    Pregabalin, Oral, 150 mg twice daily for 4 weeks
Study Arms  ICMJE
  • Experimental: A
    Tolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily
    Intervention: Drug: Tolterodine & Pregabalin
  • Active Comparator: B
    Tolterodine SR 4 mg once daily
    Intervention: Drug: Tolterodine
  • Placebo Comparator: C
    Placebo
    Intervention: Drug: Placebo
  • Experimental: D
    Tolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily
    Intervention: Drug: Tolterodine & Pregabalin
  • Experimental: E
    Pregabalin 150 mg twice daily
    Intervention: Drug: Pregabalin
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: September 3, 2008)
188
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women > 18 years Old
  • Diagnosis of OAB (micturition frequency >/= 8 times per day; urinary urgency >/= 4 times per week)

Exclusion Criteria:

  • Subjects with symptoms of overactive bladder for less than 6 months prior to randomization.
  • Significant stress incontinence as determined by the investigator e.g. stress predominant mixed incontinence, positive cough provocation test.
  • Subjects with any condition that would contraindicate the use of tolterodine or pregabalin, including: Uncontrolled narrow angle glaucoma; Urinary retention; Myasthenia gravis; Gastric retention; Severe ulcerative colitis; Toxic megacolon; Rare hereditary problems of galactose intolerance; Fructose intolerance; Sucrose-isomalate insufficiency; Lapp lactase deficiency; Glucose-galactose malabsorption.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
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 Czech Republic,   Lithuania,   Norway,   Slovakia,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00746681
Other Study ID Numbers  ICMJE A8881001
Has Data Monitoring Committee No
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 December 2009

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