search
Back to results

A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.

Primary Purpose

Urinary Bladder, Overactive

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
tolterodine extended release
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive

Eligibility Criteria

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

Inclusion Criteria:

  • self-reported symptoms of OAB for ≥ 3 months prior to screening
  • OAB as defined by urinary frequency (a minimum of 8 micturitions per 24 hours)
  • urgency (defined as a strong and sudden desire to urinate) or urge incontinence a minimum of 2 episodes in 3 days, as confirmed by the micturition diary between screening and baseline
  • patients who describe the degree of bothersomeness of their most bothersome OAB symptom as "moderately ", "a great deal ", or "a very great deal" per the OAB Bother Rating Scale

Exclusion Criteria:

  • any condition that would contraindicate their usage of tolterodine once daily, including: narrow angle glaucoma, urinary retention, gastric retention
  • any clinically significant local urinary tract pathology which could mimic the symptoms of OAB, such as infection or hematuria
  • stress incontinence, functional, or overflow incontinence as determined by the investigator
  • symptomatic acute urinary tract infection (UTI) during the run-in period, or recurrent UTIs defined by treatment for symptomatic UTI >3 times in the 12 months prior to participation in this clinical trial
  • clinically significant urinary tract obstruction
  • history of lower urinary tract surgery (e.g. prostate removal or destruction, incontinence surgery) within the past 3 months
  • clinically significant interstitial cystitis or significant bladder pain syndrome

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tolterodine ER group

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline to Week 12 in the micturition bladder diary variable related to the primary symptom of the patient at the time of study entry

Secondary Outcome Measures

OAB Bother Rating Scale at baseline
Change from baseline to Week 4 and 12 in micturition bladder diary variables
Change from baseline to Week 4 and 12 in Patient's Perception of Bladder Condition
Change from baseline to Week 4 and 12 in AUA Symptom Index
Change from baseline to Week 4 and 12 in OAB questionnaire
Clinical Global Impression-Improvement at Week 12
Overall Treatment Effect Scale of Overactive Bladder Control at Week 4 and 12
To asses the safety of tolterodine in patients with OAB

Full Information

First Posted
March 25, 2008
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00645281
Brief Title
A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.
Official Title
Symptom Specific Effectiveness of Tolterodine ER 4 mg in Patients With Symptoms of Overactive Bladder (OAB) in a Primary Care Setting. A Phase IV, Open-label, Single-arm, Non-randomized, Trial in Adult Patients With OAB.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of tolterodine in impacting the primary symptom or complaint of patients with OAB.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
896 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tolterodine ER group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
tolterodine extended release
Intervention Description
Tolterodine ER capsule 4 mg daily for 12 weeks
Primary Outcome Measure Information:
Title
Change from baseline to Week 12 in the micturition bladder diary variable related to the primary symptom of the patient at the time of study entry
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
OAB Bother Rating Scale at baseline
Time Frame
baseline
Title
Change from baseline to Week 4 and 12 in micturition bladder diary variables
Time Frame
12 weeks
Title
Change from baseline to Week 4 and 12 in Patient's Perception of Bladder Condition
Time Frame
12 weeks
Title
Change from baseline to Week 4 and 12 in AUA Symptom Index
Time Frame
12 weeks
Title
Change from baseline to Week 4 and 12 in OAB questionnaire
Time Frame
12 weeks
Title
Clinical Global Impression-Improvement at Week 12
Time Frame
12 weeks
Title
Overall Treatment Effect Scale of Overactive Bladder Control at Week 4 and 12
Time Frame
12 weeks
Title
To asses the safety of tolterodine in patients with OAB
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: self-reported symptoms of OAB for ≥ 3 months prior to screening OAB as defined by urinary frequency (a minimum of 8 micturitions per 24 hours) urgency (defined as a strong and sudden desire to urinate) or urge incontinence a minimum of 2 episodes in 3 days, as confirmed by the micturition diary between screening and baseline patients who describe the degree of bothersomeness of their most bothersome OAB symptom as "moderately ", "a great deal ", or "a very great deal" per the OAB Bother Rating Scale Exclusion Criteria: any condition that would contraindicate their usage of tolterodine once daily, including: narrow angle glaucoma, urinary retention, gastric retention any clinically significant local urinary tract pathology which could mimic the symptoms of OAB, such as infection or hematuria stress incontinence, functional, or overflow incontinence as determined by the investigator symptomatic acute urinary tract infection (UTI) during the run-in period, or recurrent UTIs defined by treatment for symptomatic UTI >3 times in the 12 months prior to participation in this clinical trial clinically significant urinary tract obstruction history of lower urinary tract surgery (e.g. prostate removal or destruction, incontinence surgery) within the past 3 months clinically significant interstitial cystitis or significant bladder pain syndrome
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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35234
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Pfizer Investigational Site
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85051
Country
United States
Facility Name
Pfizer Investigational Site
City
Sun Lakes
State/Province
Arizona
ZIP/Postal Code
85248
Country
United States
Facility Name
Pfizer Investigational Site
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
Pfizer Investigational Site
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Pfizer Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Pfizer Investigational Site
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Pfizer Investigational Site
City
Foothill Ranch
State/Province
California
ZIP/Postal Code
92610
Country
United States
Facility Name
Pfizer Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Pfizer Investigational Site
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Pfizer Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
Pfizer Investigational Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Pfizer Investigational Site
City
Chipley
State/Province
Florida
ZIP/Postal Code
32428
Country
United States
Facility Name
Pfizer Investigational Site
City
Davie
State/Province
Florida
ZIP/Postal Code
33328
Country
United States
Facility Name
Pfizer Investigational Site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Pfizer Investigational Site
City
Murdock
State/Province
Florida
ZIP/Postal Code
33948
Country
United States
Facility Name
Pfizer Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Pfizer Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Pfizer Investigational Site
City
Barnesville
State/Province
Georgia
ZIP/Postal Code
30204
Country
United States
Facility Name
Pfizer Investigational Site
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Pfizer Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30034
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Pfizer Investigational Site
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60564
Country
United States
Facility Name
Pfizer Investigational Site
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60462
Country
United States
Facility Name
Pfizer Investigational Site
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Pfizer Investigational Site
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66203
Country
United States
Facility Name
Pfizer Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Pfizer Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Pfizer Investigational Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Pfizer Investigational Site
City
Laurel
State/Province
Maryland
ZIP/Postal Code
20707
Country
United States
Facility Name
Pfizer Investigational Site
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
Pfizer Investigational Site
City
Jackson
State/Province
Michigan
Country
United States
Facility Name
Pfizer Investigational Site
City
Portage
State/Province
Michigan
ZIP/Postal Code
49002
Country
United States
Facility Name
Pfizer Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
Facility Name
Pfizer Investigational Site
City
Blackwood
State/Province
New Jersey
ZIP/Postal Code
08012
Country
United States
Facility Name
Pfizer Investigational Site
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
Pfizer Investigational Site
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Facility Name
Pfizer Investigational Site
City
Endicott
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Pfizer Investigational Site
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Pfizer Investigational Site
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
Pfizer Investigational Site
City
Beaufort
State/Province
North Carolina
ZIP/Postal Code
28516
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Facility Name
Pfizer Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Facility Name
Pfizer Investigational Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Pfizer Investigational Site
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Pfizer Investigational Site
City
Central Point
State/Province
Oregon
ZIP/Postal Code
97502
Country
United States
Facility Name
Pfizer Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Pfizer Investigational Site
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Pfizer Investigational Site
City
Bensalem
State/Province
Pennsylvania
ZIP/Postal Code
19020
Country
United States
Facility Name
Pfizer Investigational Site
City
Connellsville
State/Province
Pennsylvania
ZIP/Postal Code
15425
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19147
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Facility Name
Pfizer Investigational Site
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
Facility Name
Pfizer Investigational Site
City
Stoneboro
State/Province
Pennsylvania
ZIP/Postal Code
16153
Country
United States
Facility Name
Pfizer Investigational Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Pfizer Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Pfizer Investigational Site
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Pfizer Investigational Site
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntingdon
State/Province
Tennessee
ZIP/Postal Code
38344
Country
United States
Facility Name
Pfizer Investigational Site
City
Lexington
State/Province
Tennessee
ZIP/Postal Code
38351
Country
United States
Facility Name
Pfizer Investigational Site
City
Savannah
State/Province
Tennessee
ZIP/Postal Code
38372
Country
United States
Facility Name
Pfizer Investigational Site
City
Selmer
State/Province
Tennessee
ZIP/Postal Code
38375
Country
United States
Facility Name
Pfizer Investigational Site
City
Waynesboro
State/Province
Tennessee
ZIP/Postal Code
38485
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Pfizer Investigational Site
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Pfizer Investigational Site
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Facility Name
Pfizer Investigational Site
City
Friendswood
State/Province
Texas
ZIP/Postal Code
77546
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75093-5841
Country
United States
Facility Name
Pfizer Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Pfizer Investigational Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84084
Country
United States
Facility Name
Pfizer Investigational Site
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84120
Country
United States
Facility Name
Pfizer Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
Pfizer Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53221
Country
United States
Facility Name
Pfizer Investigational Site
City
New Berlin
State/Province
Wisconsin
ZIP/Postal Code
53151
Country
United States
Facility Name
Pfizer Investigational Site
City
Oregon
State/Province
Wisconsin
ZIP/Postal Code
53575
Country
United States
Facility Name
Pfizer Investigational Site
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6121001&StudyName=A%20Study%20to%20Evaluate%20the%20Efficacy%20of%20Tolterodine%20on%20Specific%20Symptoms%20in%20Adult%20Patients%20with%20Overactive%20Bladder.%20
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.

We'll reach out to this number within 24 hrs