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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00746681

Purpose

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.

Condition	Intervention	Phase
Urinary Bladder, Overactive	Drug: Tolterodine & Pregabalin Drug: Tolterodine Drug: Placebo Drug: Pregabalin	Phase II

MedlinePlus related topics: Urine and Urination

Drug Information available for: Tolterodine Pregabalin Tolterodine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in mean voided volume per micturition (from baseline). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	188
Study Start Date:	December 2005
Study Completion Date:	November 2006

Arms	Assigned Interventions
A: Experimental Tolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily	Drug: Tolterodine & Pregabalin Tolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks
B: Active Comparator Tolterodine SR 4 mg once daily	Drug: Tolterodine Tolterodine SR, Oral, 4 mg, once daily for 4 weeks
C: Placebo Comparator Placebo	Drug: Placebo Placebo, Oral, twice daily for 4 weeks
D: Experimental Tolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily	Drug: Tolterodine & Pregabalin Tolterodine SR Oral, 4mg, once daily for 4 weeks Pregabalin, Oral, 150 mg, twice daily for 4 weeks
E: Experimental Pregabalin 150 mg twice daily	Drug: Pregabalin Pregabalin, Oral, 150 mg twice daily for 4 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746681

Locations

Czech Republic
Pfizer Investigational Site
Hradec Kralove, Czech Republic, 500 05
Pfizer Investigational Site
Praha 3, Czech Republic, 130 00
Pfizer Investigational Site
Usti nad Labem, Czech Republic, 401 13
Pfizer Investigational Site
Praha 1, Czech Republic, 110 00
Pfizer Investigational Site
Praha 4 - Krc, Czech Republic, 140 59
Lithuania
Pfizer Investigational Site
Kaunas, Lithuania, LT-47144
Pfizer Investigational Site
Kaunas, Lithuania, LT-50009
Pfizer Investigational Site
Vilnius, Lithuania, LT-01118
Pfizer Investigational Site
Vilnius, Lithuania, LT-08661
Norway
Pfizer Investigational Site
Moelv, Norway, N-2390
Pfizer Investigational Site
Haugesund, Norway, 5507
Pfizer Investigational Site
Trondheim, Norway, 7006
Slovakia
Pfizer Investigational Site
Kosice, Slovakia, 040 11
Pfizer Investigational Site
Bratislava, Slovakia, 901 01
Pfizer Investigational Site
Skalica, Slovakia, 909 82
Pfizer Investigational Site
Martin, Slovakia
Sweden
Pfizer Investigational Site
Lulea, Sweden, 97180
Pfizer Investigational Site
Stockholm, Sweden, 141 86
Pfizer Investigational Site
Norrkoping, Sweden, 601 82
United Kingdom
Pfizer Investigational Site
Plymouth, United Kingdom, PL6 8DH
Pfizer Investigational Site
Bristol, United Kingdom, BS10 5NB
Pfizer Investigational Site
Dundee, United Kingdom, DD1 9SY
United Kingdom, Tayside
Pfizer Investigational Site
Dundee, Tayside, United Kingdom, DD1 9SY

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8881001
Study First Received:	April 2, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00746681
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases

Urinary Bladder Diseases
Pregabalin
Tolterodine

Additional relevant MeSH terms:

Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions
Muscarinic Antagonists

Urological Manifestations
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009