A 12-week multicentre, randomised, double-blind, parallel group, Phase IIpilot study to evaluate the efficacy and safety of cizolirtine citrate 200 mgbid (400 mg/d), cizolirtine citrate 300 mg bid (600 mg/d) and cizolirtinecitrate 400 mg bid (800 mg/d) versus placebo in the treatment of patientswith Stress Urinary Incontinence (SUI)

aboratorios Dr. Esteve, S.A.0 sites180 target enrollmentJune 8, 2005

Overview

No summary available.

Registry

who.int

Start Date

June 8, 2005

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

aboratorios Dr. Esteve, S.A.

•1\. Females 18\-75 years of age.
•2\. Signed informed consent form.
•3\. Clinical diagnosis of stress urinary incontinence for at least 3 months confirmed by
•medical history and documented in the subject’s file.
•4\. Presence of:
•\-more or equal to 4 incontinence episodes per week. An episode is defined as an easily
•noticeable leakage of urine that wets a pad or clothing and occurs in association
•with a physical stress such as coughing, sneezing, or exercise.
•\- Urinary diurnal frequency less or equal to 8 per day on average per week
•\- Urinary nocturnal frequency less or equal to 2 per day on average per week

•1\. Evidence of mixed incontinence or urge incontinence, or incontinence due to surgical
•treatment, according to investigator’s opinion
•2\. Evidence of exclusively nocturnal enuresis
•3\. Polyuria known from medical history and confirmed during run\-in
•4\. Concomitant treatment with drugs introduced within 3 months or with \<3 months of
•stable dosing and that can be supposed to have effects on the lower urinary tract such
•as antidepressants, neuroleptics, and calcium blocking agents.
•5\. Lower tract urological pathology in the investigator’s opinion potentially responsible for incontinence known from medical history for the last 3 months
•6\. Urinary tract infection defined in terms of clinical signs and symptoms, with or without microbiological confirmation, within 2 weeks prior to placebo run\-in (i.e. Visit 2\)
•7\. Mechanical obstructive uropathy known from medical history