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

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746681
• Other study ID #: A8881001
• Status: Completed
• Phase: Phase 2
• First received: April 2, 2008
• Last updated: December 18, 2009
• Start date: December 2005
• Est. completion date: November 2006

Study information

• Verified date: December 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Tolterodine & Pregabalin
Tolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks
• Tolterodine
Tolterodine SR, Oral, 4 mg, once daily for 4 weeks
• Placebo
Placebo, Oral, twice daily for 4 weeks
• Tolterodine & Pregabalin
Tolterodine SR Oral, 4mg, once daily for 4 weeks Pregabalin, Oral, 150 mg, twice daily for 4 weeks
• Pregabalin
Pregabalin, Oral, 150 mg twice daily for 4 weeks

Locations

Country	Name	City	State
Czech Republic	Pfizer Investigational Site	Hradec Kralove
Czech Republic	Pfizer Investigational Site	Praha 1
Czech Republic	Pfizer Investigational Site	Praha 3
Czech Republic	Pfizer Investigational Site	Praha 4 - Krc
Czech Republic	Pfizer Investigational Site	Usti Nad Labem
Lithuania	Pfizer Investigational Site	Kaunas
Lithuania	Pfizer Investigational Site	Kaunas
Lithuania	Pfizer Investigational Site	Vilnius
Lithuania	Pfizer Investigational Site	Vilnius
Norway	Pfizer Investigational Site	Haugesund
Norway	Pfizer Investigational Site	Moelv
Norway	Pfizer Investigational Site	Trondheim
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Kosice
Slovakia	Pfizer Investigational Site	Martin
Slovakia	Pfizer Investigational Site	Skalica
Sweden	Pfizer Investigational Site	Lulea
Sweden	Pfizer Investigational Site	Norrkoping
Sweden	Pfizer Investigational Site	Stockholm
United Kingdom	Pfizer Investigational Site	Bristol
United Kingdom	Pfizer Investigational Site	Dundee
United Kingdom	Pfizer Investigational Site	Dundee	Tayside
United Kingdom	Pfizer Investigational Site	Plymouth

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Czech Republic,  Lithuania,  Norway,  Slovakia,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean voided volume per micturition (from baseline).		4 weeks	No
Secondary	Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline).		4 Weeks	No
Secondary	Percentage and absolute change in urgency episode frequency		4 Weeks	No
Secondary	Mean severity of urgency episodes		4 Weeks	No
Secondary	Percentage and absolute change in micturition frequency		4 Weeks	No
Secondary	Percentage and absolute change in normalized micturition frequency (NMF)		4 Weeks	No
Secondary	Patient perception of their urinary urgency (using the OAB-q symptom severity scale)		4 Weeks	No
Secondary	Patient perception of Health Related Quality of Life (using the OAB-q SF HRQL scale)		4 Weeks	No
Secondary	Patient Perception of Bladder Condition (PPBC) scale		4 Weeks	No

External Links

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