Overactive BladderPhase 3NCT00658684
Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.
A Phase 3 study testing fesoterodine fumarate in people with Overactive Bladder, run by Pfizer at 12 sites in Japan.
Trial summary
To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB. 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?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 12 sitesJapan
- Study dates
- Feb 2008to Aug 2009
- Phase
- Phase 3
- 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 urinary urgency episodes >=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
12 sites in 1 country.
12 sites in 1 country
Japan12 sites
Pfizer Investigational Site
Akashi-shi, Hyōgo
Pfizer Investigational Site
Amagasaki-shi, Hyōgo
Pfizer Investigational Site
Chuou-ku, Koube-shi, Hyōgo
Pfizer Investigational Site
Edogawa-ku, Tokyo
Pfizer Investigational Site
Inegeku, Chibashi, Chiba
Pfizer Investigational Site
Kaibara-cho, Tanba-shi, Hyōgo
Pfizer Investigational Site
Kawasakishi, Kanagawa
Pfizer Investigational Site
Nara, Nara
Pfizer Investigational Site
Nishinomiya-shi, Hyōgo
Pfizer Investigational Site
Osaka, Osaka
Pfizer Investigational Site
Sagamihara-shi, Kanagawa
Pfizer Investigational Site
Shibuya-ku, Tokyo
About this study
Official title: An Open-Label, Multicenter, Long Term Study to Evaluate the Safety, Tolerability and Efficacy of Fesoterodine in Patients With Overactive Bladder.
To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.
- Conditions
- Overactive Bladder
- Being tested
- fesoterodine fumarate
- 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
4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fesoterodine fumarate | Experimental | Not described Receives: Drug: fesoterodine fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume
The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.
Measured: 52 Weeks
Secondary outcomes (10)
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52
The number of UUI episodes was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
The mean number of UUI episodes per 24 hours was calculated as the total number of UUI episodes for valid diary days divided by the total number of valid diary days collected at that visit.
Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Measured: Week 4, 8, 28 and 52
Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52
The number of micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
The mean number of micturitions per 24 hours was calculated as the total number of micturitions for valid diary days divided by the total number of valid diary days collected at that visit.
Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Measured: Week 4, 8, 28 and 52
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52
The 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.
The mean number of urgency episodes per 24 hours was calculated as the total number of urgency episodes for valid diary days divided by the total number of valid diary days collected at that visit.
Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Measured: Week 4, 8, 28 and 52
Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52
The 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.
The mean number of incontinence episodes per 24 hours was calculated as the total number of incontinence episodes for valid diary days divided by the total number of valid diary days collected at that visit.
Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Measured: Week 4, 8, 28 and 52
Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52
The number of nighttime micturitions was measured by the 3-day micturition diary completed for 3 consecutive days during the 7 days prior to each visit.
The mean number of nighttime micturitions per 24 hours was calculated as the total number of nighttime micturitions for valid diary days divided by the total number of valid diary days collected at that visit.
Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Measured: Week 4, 8, 28 and 52
Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52
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.
The mean voided volume per micturitions was calculated as the total voided volume for valid diary days divided by the total number of valid diary days collected at that visit.
Change: mean at Week 4, 8, 28 and 52 minus mean at Baseline
Measured: Week 4, 8, 28 and 52
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52
KHQ was used to assess the impact of bladder problems on quality of life. The scores ranged from 0 to 100, where 0=best outcome/response and 100=worst outcome/response. A negative change indicates improvement.
KHQ consists of the following domains:
- General health perceptions (GHP)
- Impact on life
- Role limitations
- Physical limitations
- Social limitations
- Personal relationships (PR)
- Emotions
- Sleep/energy
- Incontinence severity measures (ISM)
Change: mean at Week 28 and 52 minus mean at Baseline
Measured: Week 28 and 52
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52
OAB-q was used to assess the extent of subjects who had been botehred by selected bladder symptoms and to assess the effect on their health-related quality of life (HRQL). OAB-q consists of the symptom bother score(SBS), the HRQL total score and subscale scores (Coping, Concern, Sleep and Social). The SBS ranges from 0 to 100, where 0=minimal severity and 100=greatest severity (negative change indicates improvement). The HRQL scores range from 0 to 100, where 0=worst outcome and 100=best outcome (positive change indicates improvement).
Change: mean at Week 28 and 52 minus mean at baseline
Measured: Week 28 and 52
The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage
The number of subjects whose perception of bladder condition improved at least by one grade on PPBC from baseline at Week 28 and 52. The PPBC was 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: Week 28 and 52
Change From Baseline in Grade of PPBC at Week 28 and 52
The PPBC assessment was 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 28 and 52 minus mean at baseline A negative change indicates improvement.
Measured: Week 28 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2009
- Study completionAug 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 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
- NCT00658684
- Sponsor's protocol ID
- A0221006
- Other IDs
- A0221006
- Status last verified
- Oct 2010
- First submitted
- 9 Apr 2008
- Last updated
- 13 Oct 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Long Term Study to Evaluate the Safety, Tolerability and Efficacy of Fesoterodine in Patients With Overactive Bladder.
- ClinicalTrials.gov ID
- NCT00658684
- Acronym / sponsor ID
- A0221006
- Conditions
- Overactive Bladder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 15 Apr 2008 (estimated)
- Results
- Posted 11 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the long term safety, tolerability and efficacy of fesoterodine in 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 |
|---|---|---|
| Fesoterodine fumarate | 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 urinary urgency episodes >=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 fumarate4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks | Drug | Fesoterodine fumarate |
Primary outcome
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume
Time frame: 52 Weeks
The number of subjects who experienced AEs (all causality and treatment-related ) based on safety assessment during the study were summarized. The severity and seriousness of treatment-emergent AEs as well as discontinuations, dose reductions and temporary discontinuations (DR/TD) due to treatment-emergent AEs were also summarized.
10 secondary outcomes
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4, 8, 28 and 52
Time frame: Week 4, 8, 28 and 52
Change From Baseline in Mean Number of Micturitions at Week 4, 8, 28 and 52
Time frame: Week 4, 8, 28 and 52
Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Week 4, 8, 28 and 52
Time frame: Week 4, 8, 28 and 52
Change From Baseline in Mean Incontinence Episodes Per 24 Hours at Week 4, 8, 28 and 52
Time frame: Week 4, 8, 28 and 52
Change From Baseline in Number of Nighttime Micturitions Per 24 Hours at Week 4, 8, 28 and 52
Time frame: Week 4, 8, 28 and 52
Change From Baseline in Mean Voided Volume Per Micturition at Week 4, 8, 28 and 52
Time frame: Week 4, 8, 28 and 52
Change From Baseline in Score of King's Health Questionnaire (KHQ) at Week 28 and 52
Time frame: Week 28 and 52
Change From Baseline in Score of Overactive Bladder Questionnaire (OAB-q) at Week 28 and 52
Time frame: Week 28 and 52
The Number of Subjects Shifted in Patient Perception of Bladder Condition (PPBC) Responses From Baseilne to Week 28 and 52 Assessment and Its Percentage
Time frame: Week 28 and 52
Change From Baseline in Grade of PPBC at Week 28 and 52
Time frame: Week 28 and 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
- 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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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
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fesoterodine fumarate in people with Overactive Bladder, run by Pfizer at 12 sites in Japan.
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 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 11 Aug 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?
Safety Measurement Based on Adverse Events (AEs), Vital Signs, Clinical Laboratory Test, 12-lead ECG and Residual Urine Volume (time frame: 52 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 13 Oct 2010.