To compare the efficacy of fesoterodine to placebo and tolterodine ER in subjects with overactive bladder after 12 weeks of treatment.
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in mean number of urgency urinary incontinence (UUI) episodes per 24
hours at week 12 relative to the baseline (UUI episodes are defined as those
with Bladder Sensation Scale rating of 5 in the diary)
Secondary outcome
Patient's perception of Bladder Condition (PPBC)
Patient perception of Urgencu Scale (PPUS)
Overactive bladder questionnaire (OAB-q)
Dispense micturition bladder diary (3-day)
Evaluation of micturition bladder diary (3-day)
Background summary
Overactive bladder is a symptom complex of urgency, with or without urgency
incontinence, usually with frequency. Overactive bladder affects at least 10%
of the overall adult population. The majority of diagnosed patients are women,
who either develop Overactive bladder in combination with some degree of stress
incontinence or as pure OAB. As shown in the phase 3 studies, fesoterodine
(antimuscarinic for OAB treatment) has two effective, safe, and well tolerated
doses: 4mg and 8mg. Fesoterodine has been developed at a higher 8 mg dose that
offers opportunity for dose flexibility and individualization.
Study objective
To compare the efficacy of fesoterodine to placebo and tolterodine ER in
subjects with overactive bladder after 12 weeks of treatment.
Study design
This is a 12-week, randomized, double-blind, double-dummy, placebo-controlled,
parallel-group, Phase 3b, multicenter trial with fesoterodine versus
tolterodine and placebo in subjects with an overactive bladder. The subjects
will be sinitially screened at screening/enrolment visit. The randomized
subjects will be received the assigned treatment: fesoterodine, tolterodine and
placebo treatment for 12 weeks. Approximately 1675 subjects will be randomized
in this trial. The trail requirs total of 5 in-clinic visits. The trial takes
14 weeks incl. 2 weeks of follow-up.
Intervention
4 and 8 mg fesoterodine, 4 mg tolterodine and placebo, daily for 12 weeks.
Study burden and risks
Patients may undergo serveral treatments, such as physical examination,
including measurement of the vital signs (blood pressure and heart rate),
collection of blood samples and electrocardiogram (ECG). Patients will be given
a diary (4 times), 10 questionnaires to complete and collect an urine sample
during 12 weeks.
The common site effects of fesoterodine are: dry mouth, constipation, urinaru
tract infection, indigestion, dry eyes, dry throat, dirricult of painful
urination, abdominal pain, nasopharyngitis, back pain, headache, in ability to
urinate, blurred or abnormal vision. Serious side effects, for example, chest
pain and heart attack, were also reported in the fesoterodine studies.
The common site effects of tolterodine are: dry mouth, headache, fatique,
dizziness, constipation, abdominal pain, indigestion, dry eyes, abnormal
vision, sleepiness, anxiety, difficult or painful urination, in ability to
urinate.
The blood draw requires a needle stick and it may hurt, the patient may get a
bruise, an infection, feel dizzey or faint.
Rivium Westlaan 142
2909 LD Capelle a/d IJssel
Nederland
Rivium Westlaan 142
2909 LD Capelle a/d IJssel
Nederland
Listed location countries
Age
Inclusion criteria
- Overactive bladder symptoms for more than 3 months prior to screening/enrolment visit (visit 1)
- Reported at least an everage of 1 UUI episode per 24 hours in the 3-day micturition diary prior to the randomization/baseline visit (visit 2)
Exclusion criteria
-Any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment, severe ulcerative colitis, and toxic megacolon.
-Clinically significant hepatic or renal disease, and/or with a screening test of AST,ALT, ALP, urea nitrogen, or creatinine greater than 1.5 times of the upper limit of normal range (ULN)
See for more exclusion criteria p.19-21
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Clinical trails.gov |
| EudraCT | EUCTR2006-006-935-3-NL |
| CCMO | NL17592.091.07 |