Overactive BladderPhase 2NCT00561951
Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo For Overactive Bladder.
A Phase 2 study testing fesoterodine fumarate in people with Overactive Bladder, run by Pfizer at 65 sites in 4 countries.
Trial summary
To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- fesoterodine fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 951 participants
- Where
- 65 sitesin 4 countries
- Study dates
- Nov 2007to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urgency urinary incontinence >= 1 per day.
Who cannot join
- Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
- Patient has a known neurological disease influencing bladder function.
- Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.
Trial locations and contacts
65 sites in 4 countries.
65 sites in 4 countries
Japan52 sites
Pfizer Investigational Site
Aira-gun, Aira-chou,, Kagoshima-ken
Pfizer Investigational Site
Amagasaki-shi, Hyōgo
Pfizer Investigational Site
Bunkyo-ku, Tokyo
Pfizer Investigational Site
Chofu-shi, Tokyo
Pfizer Investigational Site
Chuo-ku, Tokyo
Pfizer Investigational Site
Chuo-ku, Chiba-shi, Chiba
Pfizer Investigational Site
Chuou-shi, Yamanashi
Pfizer Investigational Site
Eiheiji-cyo,yoshida-gun,, Fukui
Pfizer Investigational Site
Fucyushi, Tokyo
Pfizer Investigational Site
Fukuoka, Fukuoka
Pfizer Investigational Site
Gotenbashi, Shizuoka
Pfizer Investigational Site
Higashinada, Hyōgo
Pfizer Investigational Site
Hunaki-cho, Ibaraki-shi, Osaka
Pfizer Investigational Site
Isogo-ku, Yokohama-shi, Kanagawa
Pfizer Investigational Site
Kawasakishi, Kanagawa
Pfizer Investigational Site
Kita-ku, Osaka-shi, Osaka
Pfizer Investigational Site
Kochi, Kochi
Pfizer Investigational Site
Koga-shi, Fukuoka
Pfizer Investigational Site
Kosobe-cho, Takatsuki-shi, Osaka
Pfizer Investigational Site
Koto-ku, Tokyo
Pfizer Investigational Site
Kumamoto, Kumamoto
Pfizer Investigational Site
Matsumoto-shi, Nagano
Pfizer Investigational Site
Matumoto-Shi, Nagano
Pfizer Investigational Site
Minami-ku, Fukuoka-shi, Fukuoka
Pfizer Investigational Site
Minami-ku, Sakai-shi, Osaka
Pfizer Investigational Site
Nada-ku, Kobe-shi, Hyōgo
Pfizer Investigational Site
Nagoya, Aichi-ken
Pfizer Investigational Site
Nakano-ku, Tokyo
Pfizer Investigational Site
Nishi-Tokyo-shi, Tokyo
Pfizer Investigational Site
Nishiku, Fukuoka
Pfizer Investigational Site
Nishinari-ku, Osaka
Pfizer Investigational Site
Osaka, Osaka
Pfizer Investigational Site
Sagamihara-shi, Kanagawa
Pfizer Investigational Site
Saitama-shi, Saitama
Pfizer Investigational Site
Satte-shi, Saitama
Pfizer Investigational Site
Sawara-ku, Fukuoka
Pfizer Investigational Site
Setagaya-ku, Tokyo
Pfizer Investigational Site
Setgaya-ku, Tokyo
Pfizer Investigational Site
Shibuya-ku, Tokyo
Pfizer Investigational Site
Shinjuku-ku, Tokyo
Pfizer Investigational Site
Suginami-ku, Tokyo
Pfizer Investigational Site
Suita-shi, Osaka
Pfizer Investigational Site
Suita-shi,, Osaka
Pfizer Investigational Site
Suma-ku, Kobe-shi, Hyōgo
Pfizer Investigational Site
Sumida-ku, Tokyo
Pfizer Investigational Site
Susono, Shizuoka
Pfizer Investigational Site
Takaraduka-city, Hyōgo
Pfizer Investigational Site
Tama-ku, Kawasaki-shi, Kanagawa
Pfizer Investigational Site
Tamana-shi, Kumamoto
Pfizer Investigational Site
Toyonaka, Osaka
Pfizer Investigational Site
Wakou-shi, Saitama
Pfizer Investigational Site
Yodogawa-Ku, Osaka
Taiwan6 sites
Pfizer Investigational Site
Chiayi Country, 613
Pfizer Investigational Site
Hualien City, 970
Pfizer Investigational Site
Koahsiung, 833
Pfizer Investigational Site
Taichung, 402
Pfizer Investigational Site
Taipei, 100
Pfizer Investigational Site
Taipei, 112
South Korea5 sites
Pfizer Investigational Site
Cheonan-si, Chungcheongnam-do, 330-715
Pfizer Investigational Site
Pusan, 602-739
Pfizer Investigational Site
Seoul, 100-380
Pfizer Investigational Site
Seoul, 136-705
Pfizer Investigational Site
Seoul, 138-736
Hong Kong2 sites
Pfizer Investigational Site
Kowloon
Pfizer Investigational Site
Shatin
About this study
Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo In Patients With Overactive Bladder.
To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder.
- Conditions
- Overactive Bladder
- Being tested
- fesoterodine fumarate, Placebo
- 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.
fesoterodine fumarateDrug
8mg tablets OD for 12 weeks
PlaceboDrug
Corresponding placebo tablets OD for 12 weeks
fesoterodine fumarateDrug
4mg tablets OD for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fesoterodine fumarate 4 mg (Double-Blind) | Experimental | Not described Receives: Drug: fesoterodine fumarate |
| Placebo (Double-Blind) | Placebo comparator | Not described Receives: Drug: Placebo |
| Fesoterodine fumarate 8 mg (Double-Blind) | Experimental | Not described Receives: Drug: fesoterodine fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.
Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Change: mean at Week 12 minus mean at Baseline.
Measured: Baseline to Week 12
Secondary outcomes (15)
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Number of urgency urinary incontinence (UUI) episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Change: mean at each visit minus mean at Baseline.
Measured: Baseline to Weeks 2, 4, 8, and 12
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.
Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at Week 12 minus mean at Baseline.
Measured: Baseline to Week 12
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at each visit minus mean at Baseline.
Measured: Baseline to Weeks 2, 4, 8, and 12
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.
Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Change: mean at Week 12 minus mean at Baseline.
Measured: Baseline to Week 12
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Number of urgency episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Change: mean at each visit minus mean at Baseline.
Measured: Baseline to Weeks 2, 4, 8, and 12
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.
Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Incontinence is the complaint of any involuntary leakage of urine.
Change: mean at Week 12 minus mean at Baseline.
Measured: Baseline to Week 12
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Number of incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Incontinence is the complaint of any involuntary leakage of urine.
Change: mean at each visit minus mean at Baseline.
Measured: Baseline to Weeks 2, 4, 8, and 12
Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.
Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at Week 12 minus mean at Baseline.
Measured: Baseline to Week 12
Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Number of Night-Time Micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at each visit minus mean at Baseline.
Measured: Baseline to Weeks 2, 4, 8, and 12
Change From Baseline in Mean Voided Volume Per Micturition at Week 12.
Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Voided volume was recorded during any 1 day of 3-day diary period through the first micturition of the next day.
Change: mean at Week 12 minus mean at Baseline.
Measured: Baseline to Week 12
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.
Voided volume per micturition was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
Change: mean at each visit minus mean at Baseline.
Measured: Baseline to Weeks 2, 4, 8, and 12
Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
King's Health Questionnaire(KHQ) is used to assess the impact of bladder problems on quality of life. The each domain score was calculated valued and ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response.
Change: mean at Week 12 minus mean at Baseline.
Measured: Baseline to Week12
Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.
The overactive bladder questionnaire (OAB-q) is used to assess the extent of participants who had been bothered by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL).
The each domain score ranges from 0 to 100 is a calculated value, where 0=minimal symptom severity and 100=greatest symptom severity for Symptom Bother Score, and where 0=worst HRQL outcome/response and 100=best HRQL outcome/response for HRQL domains including total score of HROL domain.
Change: mean at Week 12 minus mean at Baseline.
Measured: Baseline to Week 12
Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.
Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:
- No problems at all
- Some very minor problems
- Some minor problems
- Some moderate problems
- Severe problems
- Many severe problems
Change: mean at Week 12 minus mean at Baseline.
Measured: Baseline to Week 12
The Number of Patients With "Severe Problems, Score 5" or "Many Severe Problems, Score 6" in Patient Perception of Bladder Condition (PPBC) at Week 12.
Patient Perception of Bladder Condition (PPBC) score is rated on a 6-point scale as follows:
- No problems at all
- Some very minor problems
- Some minor problems
- Some moderate problems
- Severe problems
- Many severe problems
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 951 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561951
- Sponsor's protocol ID
- A0221005
- Status last verified
- Jul 2011
- First submitted
- 19 Nov 2007
- Last updated
- 14 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Dose-Finding Study To Evaluate The Efficacy, Tolerability And Safety Of Fesoterodine In Comparison To Placebo In Patients With Overactive Bladder.
- ClinicalTrials.gov ID
- NCT00561951
- Acronym / sponsor ID
- A0221005
- Conditions
- Overactive Bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 951 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 21 Nov 2007 (estimated)
- Results
- Posted 9 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fesoterodine fumarate 4 mg (Double-Blind) | Experimental | Drug: fesoterodine fumarate |
| Placebo (Double-Blind) | Placebo comparator | Drug: Placebo |
| Fesoterodine fumarate 8 mg (Double-Blind) | Experimental | Drug: fesoterodine fumarate |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult OAB patients who present with OAB symptoms, including micturitions >= 8 per day and urgency urinary incontinence >= 1 per day.
Key exclusion criteria (3 listed)
- Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
- Patient has a known neurological disease influencing bladder function.
- Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.
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 |
|---|---|---|
| fesoterodine fumarate8mg tablets OD for 12 weeks | Drug | Fesoterodine fumarate 8 mg (Double-Blind) |
| PlaceboCorresponding placebo tablets OD for 12 weeks | Drug | Placebo (Double-Blind) |
| fesoterodine fumarate4mg tablets OD for 12 weeks | Drug | Fesoterodine fumarate 4 mg (Double-Blind) |
Primary outcome
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.
Time frame: Baseline to Week 12
Number of urgency urinary incontinence episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit. Urgency urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency. Urgency is the complaint of a sudden compelling desire to pass urine which is difficult to defer. Change: mean at Week 12 minus mean at Baseline.
15 secondary outcomes
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Weeks 2, 4, 8, and 12
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.
Time frame: Baseline to Week 12
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Weeks 2, 4, 8, and 12
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 12.
Time frame: Baseline to Week 12
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Weeks 2, 4, 8, and 12
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Week 12.
Time frame: Baseline to Week 12
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Weeks 2, 4, 8, and 12
Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Week 12.
Time frame: Baseline to Week 12
Change From Baseline in Mean Number of Night-Time Micturitions Per 24 Hours at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Weeks 2, 4, 8, and 12
Change From Baseline in Mean Voided Volume Per Micturition at Week 12.
Time frame: Baseline to Week 12
Change From Baseline in Mean Voided Volume Per Micturition at Weeks 2, 4, 8, and 12.
Time frame: Baseline to Weeks 2, 4, 8, and 12
Change From Baseline in Each Domain Scores of King's Health Questionnaire (KHQ).
Time frame: Baseline to Week12
Change From Baseline in Each Domain Scores of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Time frame: Baseline to Week 12
Change From Baseline for Patient Perception of Bladder Condition (PPBC) at Week 12.
Time frame: Baseline to Week 12
The Number of Patients With "Severe Problems, Score 5" or "Many Severe Problems, Score 6" in Patient Perception of Bladder Condition (PPBC) at Week 12.
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
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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
65 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fesoterodine fumarate in people with Overactive Bladder, run by Pfizer at 65 sites in 4 countries.
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 1 inclusion and 3 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 14 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in Japan, Taiwan, South Korea, Hong Kong. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. (time frame: Baseline to Week 12). 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 14 Jul 2011.