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
  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
Overactive Bladder
Drug: Tolterodine & Pregabalin
Drug: Tolterodine
Drug: Placebo
Drug: Pregabalin
Phase 2

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

Resource links provided by NLM:


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
Experimental: A
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
Active Comparator: B
Tolterodine SR 4 mg once daily
Drug: Tolterodine
Tolterodine SR, Oral, 4 mg, once daily for 4 weeks
Placebo Comparator: C
Placebo
Drug: Placebo
Placebo, Oral, twice daily for 4 weeks
Experimental: D
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
Experimental: E
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 1, Czech Republic, 110 00
Pfizer Investigational Site
Praha 3, Czech Republic, 130 00
Pfizer Investigational Site
Praha 4 - Krc, Czech Republic, 140 59
Pfizer Investigational Site
Usti Nad Labem, Czech Republic, 401 13
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
Haugesund, Norway, 5507
Pfizer Investigational Site
Moelv, Norway, N-2390
Pfizer Investigational Site
Trondheim, Norway, 7006
Slovakia
Pfizer Investigational Site
Bratislava, Slovakia, 901 01
Pfizer Investigational Site
Kosice, Slovakia, 040 11
Pfizer Investigational Site
Martin, Slovakia
Pfizer Investigational Site
Skalica, Slovakia, 909 82
Sweden
Pfizer Investigational Site
Lulea, Sweden, 97180
Pfizer Investigational Site
Norrkoping, Sweden, 601 82
Pfizer Investigational Site
Stockholm, Sweden, 141 86
United Kingdom
Pfizer Investigational Site
Dundee, Tayside, United Kingdom, DD1 9SY
Pfizer Investigational Site
Bristol, United Kingdom, BS10 5NB
Pfizer Investigational Site
Dundee, United Kingdom, DD1 9SY
Pfizer Investigational Site
Plymouth, United Kingdom, PL6 8DH
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00746681     History of Changes
Other Study ID Numbers: A8881001
Study First Received: April 2, 2008
Last Updated: December 18, 2009
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Pregabalin
Phenylpropanolamine
Tolterodine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Urological Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Appetite Depressants

ClinicalTrials.gov processed this record on September 14, 2014