An evaluation of the dose-response relationship of Cizolirtine citrate 300 mg, twice daily, and 400 mg, twice daily, versus placebo in subjects with urge urinary incontinence.A 12-week, randomised, double-blind, placebo-controlled, multicentre study, parallel-group, Phase III clinical study with a 12 months safety follow-up period.

aboratorios Dr. Esteve, SA0 sites450 target enrollmentSeptember 17, 2004

Conditionsrge Urinary Incontinence

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: rge Urinary Incontinence
Sponsor: aboratorios Dr. Esteve, SA
Enrollment: 450
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 17, 2004

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

aboratorios Dr. Esteve, SA

Eligibility Criteria

Inclusion Criteria

•1\. Males and females 18 to 75 years of age.
•2\. Signed informed consent.
•3\. Subjects without any medication, or with ineffective and/or unsatisfactory current medication for OAB, specifically UUI, or subjects with a history of ineffective and/or unsatisfactory medication and currently without medication for OAB (UUI)
•4\. Subjects with a history of at least 6 months UUI.
•The subject may be included in the study if all of the criteria at the screening visit along with all of the following criteria at the baseline visit are fulfilled:
•5\. Subjects able to co\-operate
•6\. Subjects able to accurately complete the micturition diary during 7 days in the run\-in period.
•7\. At least 1 urgency episode/24 h accompanied by at least one incontinence episode/24 h or in average at least 8 micturitions/24 h during 7 days within 14 days prior to the randomisation visit, as quantified from the subject’s micturition diary.
•8\. Sterile urine with absence of pyuria as confirmed by dip\-stick urine test.
•Are the trial subjects under 18? no

Exclusion Criteria

•1\. Stress incontinence, or any other reason for incontinence aside from urge incontinence, as determined by the investigator.
•2\. Polyuria – more than 40 mL/kg bodyweight per 24 hours.
•3\. Concomitant treatment with non\-stable doses of drugs that can be supposed to have effects on the lower urinary tract such as antidepressants, neuroleptics, calcium blocking agents.
•4\. Any obstructive condition affecting the urethra or any prostatic disease, like benign hypertrophy, neoplasm, or prostatitis of clinical relevance.
•5\. Concomitant pharmacological treatment of OAB (UUI) or stress urinary incontinence with any drug different to that of the study. If the subject is using such a drug, it has to discontinued and the screening period extended to three weeks for the subject to be eligible for the study. If oestrogens are administered as treatment for UUI the dose must be stable during at least eight weeks prior to the screening visit for the subject to be eligible for the study, and continued during the study.
•6\. Urogenital surgery, such as prostatectomy or a surgical treatment of the incontinence within the last 6 months.
•7\. Concomitant conservative treatment for urinary incontinence such as vaginal cones, devices, behavioural therapy, intermittent urinary catheter, electrical stimulation etc.
•8\. Hepatic disease (defined as twice the upper limit of the reference range for liver function test).
•9\. Renal disease (defined as twice the upper limit of the reference range for creatinine).
•10\. Any history of cerebral stroke.