Clinical trial NCT00746681: Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-04
Enrollment: 188
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in mean voided volume per micturition (from baseline).
timeFrame: 4 weeks
Secondary outcomes:
measure: Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline).
timeFrame: 4 Weeks
measure: Percentage and absolute change in urgency episode frequency
timeFrame: 4 Weeks
measure: Mean severity of urgency episodes
timeFrame: 4 Weeks
measure: Percentage and absolute change in micturition frequency
timeFrame: 4 Weeks
measure: Percentage and absolute change in normalized micturition frequency (NMF)
timeFrame: 4 Weeks
measure: Patient perception of their urinary urgency (using the OAB-q symptom severity scale)
timeFrame: 4 Weeks
measure: Patient perception of Health Related Quality of Life (using the OAB-q SF HRQL scale)
timeFrame: 4 Weeks
measure: Patient Perception of Bladder Condition (PPBC) scale
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 1
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 3
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 4 - Krc
country: Czech Republic
facility: Pfizer Investigational Site
city: Usti Nad Labem
country: Czech Republic
facility: Pfizer Investigational Site
city: Kaunas
country: Lithuania
facility: Pfizer Investigational Site
city: Kaunas
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Haugesund
country: Norway
facility: Pfizer Investigational Site
city: Moelv
country: Norway
facility: Pfizer Investigational Site
city: Trondheim
country: Norway
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Martin
country: Slovakia
facility: Pfizer Investigational Site
city: Skalica
country: Slovakia
facility: Pfizer Investigational Site
city: Lulea
country: Sweden
facility: Pfizer Investigational Site
city: Norrkoping
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
state: Tayside
city: Bristol
country: United Kingdom
facility: Pfizer Investigational Site
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
city: Plymouth
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: