To evaluate the dose-response relationship of SVT-404776 on efficacy.
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in the number of micturitions per 24 hours from baseline to the end
of the double-blind treatment period.
Secondary outcome
Number of urge incontinence episodes, number of urgency (without incontinence)
episodes, number of incontinence episodes, number of voids (micturitions plus
incontinence episodes), number of urgency episodes, number of nocturia
episodes, number of continent days and volume of urine passed per void.
Background summary
Overactive bladder (OAB) syndrome is the most common cause of urinary
incontinence and is characterised by the following: urgency (an immediate,
unstoppable urge to urinate), with or without urge urinary incontinence (the
complaint of involuntary leakage accompanied by or immediately preceded by
urgency) usually with frequency (urinating too often and at too frequent
intervals) and nocturia (excessive urination at night).
The standard treatment for OAB is currently antimuscarinic drugs, which work by
relaxing the muscle within the bladder to help increase the bladder capacity.
SVT-40776 belongs to this class of drugs.
Study objective
To evaluate the dose-response relationship of SVT-404776 on efficacy.
Study design
A multicentre, parallel-design. placebo and active-treatment controlled,
randomised, double-blind, dose ranging study.
Intervention
Patients will be randomised to receive either 0.05 mg SVT-40776, 0.1 mg
SVT-40776, 0.2 mg SVT-40776, 4 mg tolterodine or placebo.
Study burden and risks
Patients will visit the clinic for a total of 5 times every 2 weeks, the
duration of a visit will not exceed 3 hours. Patients need to fill out a diary
and at every visit they will need to fill out a questionnaire. During every
visit a physical examination will take place and an ECG is made and every 4
weeks blood and urine will be collected. Women with childbearing potential
need to use an acceptable method of anticonception, and every visit a pregnancy
test will be performed. During screening an uroflow, an
urological/gynaecological and ophthalmological exam and if necessary a
cystometry will be performed.
There may be some side effects and discomforts associated with the study drug.
SVT-40776 belongs to the antimuscarinic class of drug. SVT-40776 is in the
early stage of development and the extent of the side effects for this drug are
not fully known. Early clinical studies suggest that SVT-40776 is well
tolerated with dry mouth, visual disturbance and dizziness being the most
commonly reported side effects. There may also be side effects and discomforts
that are not yet known.
In addition, patients might experience some discomfort from blood sampling and
ECG recording. Cystometry usually causes some discomfort and adverse effects.
The mild irritation of the urinary tract necessary for insertion of a bladder
catheter may occasionally cause flushing, sweating and nausea. Urinary
frequency or urgency, and some reddening of the urine, may last for a day after
the procedure. There is a slight risk of problems caused by insertion of the
catheter and this can lead to infection.
The expected side effects of SVT-40776 are most likely less serious as in other
antimuscarinic drugs, and therefore it is useful and justified to investigate
the dose-response on effectiveness.
Gall, 30-36
08950 Esplugues de Llobregat, Barcelona
Spain
Gall, 30-36
08950 Esplugues de Llobregat, Barcelona
Spain
Listed location countries
Age
Inclusion criteria
Patients suffering from OAB based on three cardinal symptoms (urgency with or without urge incontinence, usually accompanied by frequency or nocturia) for at least 6 months prior to inclusion
Patients must document during the 14-day placebo run-in period an average of ><= 10 micturitions/ 24 hours and either a total of ><= 3 incontinence episodes or a total of ><= 3 urgency episodes in the patient diary
Exclusion criteria
Patients with clinically significant bladder neck obstructions defined as post-void residual urine volumes grater than 100mL.
Patients with free uroflow <15 mL/ sec in males or <10 mL/sec in females.
Patients with clinically predominant stress incontinence (>=2 episodes per week)
Patients suffering from neurologic diseases that could cause neurogenic incontinence.
Patients with significant urogenital or gastrointestinal disease.
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 |
|---|---|
| EudraCT | EUCTR2006-001378-26-NL |
| CCMO | NL12449.018.06 |