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Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00746681
First received: April 2, 2008
Last updated: December 18, 2009
Last verified: December 2009

April 2, 2008
December 18, 2009
December 2005
Not Provided
Change in mean voided volume per micturition (from baseline). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00746681 on ClinicalTrials.gov Archive Site
  • Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline). [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Percentage and absolute change in urgency episode frequency [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Mean severity of urgency episodes [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Percentage and absolute change in micturition frequency [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Percentage and absolute change in normalized micturition frequency (NMF) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Patient perception of their urinary urgency (using the OAB-q symptom severity scale) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Patient perception of Health Related Quality of Life (using the OAB-q SF HRQL scale) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Patient Perception of Bladder Condition (PPBC) scale [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Overactive Bladder
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
188
November 2006
Not Provided

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Lithuania,   Norway,   Slovakia,   Sweden,   United Kingdom
 
NCT00746681
A8881001
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2009

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