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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Hradec Kralove, , 500 05 Czech Republic
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder
Sex
Female
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

- Women > 18 years Old

- Diagnosis of OAB (micturition frequency >/= 8 times per day; urinary urgency >/= 4
times per week)

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

- 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.

NCT00746681
Pfizer
Completed
Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder

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Similar Trials

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
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Lithuania,   Norway,   Slovakia,   Sweden,   United Kingdom
 
 
NCT00746681
A8881001
No
Not Provided
Not Provided
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

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