Urinary Bladder, OveractivePhase 4NCT00645281
A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.
A Phase 4 study testing tolterodine extended release in people with Urinary Bladder, Overactive, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 96 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- tolterodine extended release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 896 participants
- Where
- 96 sitesUnited States
- Study dates
- Mar 2004to Jan 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
96 sites in 1 country.
96 sites in 1 country
United States96 sites
Pfizer Investigational Site
Atlanta, Georgia, 30308
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Bala-Cynwyd, Pennsylvania, 19004
Pfizer Investigational Site
Barnesville, Georgia, 30204
Pfizer Investigational Site
Beaufort, North Carolina, 28516
Pfizer Investigational Site
Bensalem, Pennsylvania, 19020
Pfizer Investigational Site
Bentonville, Arkansas, 72712
Pfizer Investigational Site
Binghamton, New York, 13901
Pfizer Investigational Site
Birmingham, Alabama, 35211
Pfizer Investigational Site
Birmingham, Alabama, 35213
Pfizer Investigational Site
Birmingham, Alabama, 35234
Pfizer Investigational Site
Blackwood, New Jersey, 08012
Pfizer Investigational Site
Blue Ridge, Georgia, 30513
Pfizer Investigational Site
Bryan, Texas, 77802
Pfizer Investigational Site
Buena Park, California, 90620
Pfizer Investigational Site
Central Point, Oregon, 97502
Pfizer Investigational Site
Charlotte, North Carolina, 28207
Pfizer Investigational Site
Charlotte, North Carolina, 28262
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Chipley, Florida, 32428
Pfizer Investigational Site
Colleyville, Texas, 76034
Pfizer Investigational Site
Colorado Springs, Colorado, 80904
Pfizer Investigational Site
Columbus, Ohio, 43213
Pfizer Investigational Site
Connellsville, Pennsylvania, 15425
Pfizer Investigational Site
Cordova, Tennessee, 38018
Pfizer Investigational Site
Davie, Florida, 33328
Pfizer Investigational Site
Decatur, Georgia, 30034
Pfizer Investigational Site
Durham, North Carolina, 27703
Pfizer Investigational Site
Endicott, New York, 13760
Pfizer Investigational Site
Endwell, New York, 13760
Pfizer Investigational Site
Foothill Ranch, California, 92610
Pfizer Investigational Site
Fresno, California, 93710
Pfizer Investigational Site
Friendswood, Texas, 77546
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Hallandale, Florida, 33009
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Huntingdon, Tennessee, 38344
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Jackson, Michigan
Pfizer Investigational Site
Jonesboro, Arkansas, 72401
Pfizer Investigational Site
Kettering, Ohio, 45429
Pfizer Investigational Site
Kingston, New York, 12401
Pfizer Investigational Site
Lakewood, Colorado, 80228
Pfizer Investigational Site
Las Vegas, Nevada, 89128
Pfizer Investigational Site
Las Vegas, Nevada, 89146
Pfizer Investigational Site
Laurel, Maryland, 20707
Pfizer Investigational Site
Lexington, Tennessee, 38351
Pfizer Investigational Site
Little Rock, Arkansas, 72204
Pfizer Investigational Site
Marrero, Louisiana, 70072
Pfizer Investigational Site
Medford, Oregon, 97504
Pfizer Investigational Site
Miami, Florida, 33145
Pfizer Investigational Site
Miami Beach, Florida, 33140
Pfizer Investigational Site
Milwaukee, Wisconsin, 53221
Pfizer Investigational Site
Montgomery, Alabama, 36117
Pfizer Investigational Site
Morehead City, North Carolina, 28557
Pfizer Investigational Site
Mount Laurel, New Jersey, 08054
Pfizer Investigational Site
Murdock, Florida, 33948
Pfizer Investigational Site
Naperville, Illinois, 60564
Pfizer Investigational Site
New Berlin, Wisconsin, 53151
Pfizer Investigational Site
Newton, Kansas, 67114
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Oregon, Wisconsin, 53575
Pfizer Investigational Site
Orland Park, Illinois, 60462
Pfizer Investigational Site
Oxon Hill, Maryland, 20745
Pfizer Investigational Site
Pembroke Pines, Florida, 33024
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19103
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19147
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19148
Pfizer Investigational Site
Phoenix, Arizona, 85051
Pfizer Investigational Site
Plano, Texas, 75093-5841
Pfizer Investigational Site
Plano, Texas, 75093
Pfizer Investigational Site
Portage, Michigan, 49002
Pfizer Investigational Site
Saint Cloud, Florida, 34769
Pfizer Investigational Site
Salt Lake City, Utah, 84109
Pfizer Investigational Site
Salt Lake City, Utah, 84121
Pfizer Investigational Site
San Antonio, Texas, 78217
Pfizer Investigational Site
Savannah, Tennessee, 38372
Pfizer Investigational Site
Sellersville, Pennsylvania, 18960
Pfizer Investigational Site
Selmer, Tennessee, 38375
Pfizer Investigational Site
Shawnee Mission, Kansas, 66203
Pfizer Investigational Site
Simpsonville, South Carolina, 29681
Pfizer Investigational Site
Spokane, Washington, 99207
Pfizer Investigational Site
Spokane, Washington, 99208
Pfizer Investigational Site
St Louis, Missouri, 63117
Pfizer Investigational Site
Stoneboro, Pennsylvania, 16153
Pfizer Investigational Site
Sun Lakes, Arizona, 85248
Pfizer Investigational Site
Tampa, Florida, 33607
Pfizer Investigational Site
Warwick, Rhode Island, 02886
Pfizer Investigational Site
Wauwatosa, Wisconsin, 53226
Pfizer Investigational Site
Waynesboro, Tennessee, 38485
Pfizer Investigational Site
West Covina, California, 91790
Pfizer Investigational Site
West Jordan, Utah, 84084
Pfizer Investigational Site
West Valley City, Utah, 84120
Pfizer Investigational Site
Wichita, Kansas, 67205
Pfizer Investigational Site
Wichita, Kansas, 67207
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
About this study
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.
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.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- tolterodine extended release
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tolterodine extended releaseDrug
Tolterodine ER capsule 4 mg daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| tolterodine ER group | Experimental | Not described Receives: Drug: tolterodine extended release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (8)
OAB Bother Rating Scale at baseline
Measured: baseline
Change from baseline to Week 4 and 12 in micturition bladder diary variables
Measured: 12 weeks
Change from baseline to Week 4 and 12 in Patient's Perception of Bladder Condition
Measured: 12 weeks
Change from baseline to Week 4 and 12 in AUA Symptom Index
Measured: 12 weeks
Change from baseline to Week 4 and 12 in OAB questionnaire
Measured: 12 weeks
Clinical Global Impression-Improvement at Week 12
Measured: 12 weeks
Overall Treatment Effect Scale of Overactive Bladder Control at Week 4 and 12
Measured: 12 weeks
To asses the safety of tolterodine in patients with OAB
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startMar 2004
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 896 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645281
- Sponsor's protocol ID
- A6121001
- Status last verified
- Jan 2021
- First submitted
- 25 Mar 2008
- Last updated
- 27 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00645281
- Acronym / sponsor ID
- A6121001
- Conditions
- Urinary Bladder, Overactive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 896 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Jan 2005 (actual)
- First posted
- 27 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tolterodine ER group | Experimental | Drug: tolterodine extended release |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tolterodine extended releaseTolterodine ER capsule 4 mg daily for 12 weeks | Drug | tolterodine ER group |
Primary outcome
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
8 secondary outcomes
OAB Bother Rating Scale at baseline
Time frame: baseline
Change from baseline to Week 4 and 12 in micturition bladder diary variables
Time frame: 12 weeks
Change from baseline to Week 4 and 12 in Patient's Perception of Bladder Condition
Time frame: 12 weeks
Change from baseline to Week 4 and 12 in AUA Symptom Index
Time frame: 12 weeks
Change from baseline to Week 4 and 12 in OAB questionnaire
Time frame: 12 weeks
Clinical Global Impression-Improvement at Week 12
Time frame: 12 weeks
Overall Treatment Effect Scale of Overactive Bladder Control at Week 4 and 12
Time frame: 12 weeks
To asses the safety of tolterodine in patients with OAB
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
96 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tolterodine extended release in people with Urinary Bladder, Overactive, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 96 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.