search
Back to results

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

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tolterodine & Pregabalin
Tolterodine
Placebo
Tolterodine & Pregabalin
Pregabalin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Experimental

Experimental

Arm Label

A

B

C

D

E

Arm Description

Tolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily

Tolterodine SR 4 mg once daily

Placebo

Tolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily

Pregabalin 150 mg twice daily

Outcomes

Primary Outcome Measures

Change in mean voided volume per micturition (from baseline).

Secondary Outcome Measures

Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline).
Percentage and absolute change in urgency episode frequency
Mean severity of urgency episodes
Percentage and absolute change in micturition frequency
Percentage and absolute change in normalized micturition frequency (NMF)
Patient perception of their urinary urgency (using the OAB-q symptom severity scale)
Patient perception of Health Related Quality of Life (using the OAB-q SF HRQL scale)
Patient Perception of Bladder Condition (PPBC) scale

Full Information

First Posted
April 2, 2008
Last Updated
December 18, 2009
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00746681
Brief Title
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

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Tolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily
Arm Title
B
Arm Type
Active Comparator
Arm Description
Tolterodine SR 4 mg once daily
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
D
Arm Type
Experimental
Arm Description
Tolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily
Arm Title
E
Arm Type
Experimental
Arm Description
Pregabalin 150 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Tolterodine & Pregabalin
Intervention Description
Tolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Tolterodine
Intervention Description
Tolterodine SR, Oral, 4 mg, once daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, Oral, twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Tolterodine & Pregabalin
Intervention Description
Tolterodine SR Oral, 4mg, once daily for 4 weeks Pregabalin, Oral, 150 mg, twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Pregabalin, Oral, 150 mg twice daily for 4 weeks
Primary Outcome Measure Information:
Title
Change in mean voided volume per micturition (from baseline).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline).
Time Frame
4 Weeks
Title
Percentage and absolute change in urgency episode frequency
Time Frame
4 Weeks
Title
Mean severity of urgency episodes
Time Frame
4 Weeks
Title
Percentage and absolute change in micturition frequency
Time Frame
4 Weeks
Title
Percentage and absolute change in normalized micturition frequency (NMF)
Time Frame
4 Weeks
Title
Patient perception of their urinary urgency (using the OAB-q symptom severity scale)
Time Frame
4 Weeks
Title
Patient perception of Health Related Quality of Life (using the OAB-q SF HRQL scale)
Time Frame
4 Weeks
Title
Patient Perception of Bladder Condition (PPBC) scale
Time Frame
4 Weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 1
ZIP/Postal Code
110 00
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 3
ZIP/Postal Code
130 00
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 4 - Krc
ZIP/Postal Code
140 59
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Usti Nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Kaunas
ZIP/Postal Code
LT-47144
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Vilnius
ZIP/Postal Code
LT-01118
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Haugesund
ZIP/Postal Code
5507
Country
Norway
Facility Name
Pfizer Investigational Site
City
Moelv
ZIP/Postal Code
N-2390
Country
Norway
Facility Name
Pfizer Investigational Site
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
901 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Kosice
ZIP/Postal Code
040 11
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Martin
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Skalica
ZIP/Postal Code
909 82
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Lulea
ZIP/Postal Code
97180
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Norrkoping
ZIP/Postal Code
601 82
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Dundee
State/Province
Tayside
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bristol
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8881001&StudyName=Investigation%20of%20tolterodine%2C%20pregabalin%20and%20a%20tolterodine%20-%20pregabalin%20combination%20for%20the%20treatment%20of%20overactive%20bladder.
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs