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)

• Conditions: Stress Urinary Incontinence

• Registration Number: EUCTR2005-000107-33-SE
• Lead Sponsor: aboratorios Dr. Esteve, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-08
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

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
5. Ability to in supine position tolerate filling of the bladder with 400 ml saline without a
first leakage at <100 ml.
6. Positive cough stress test (visualisation of urine leakage concurrent with cough)
7. Positive standardised 1 hour stress pad test (leakage of > 2.0 g)
8. Sterile urine and normal basic urinalysis (analyses available at Visit 2)
9. Subjects willing and able to co-operate
10. Subjects able to accurately complete the patient diary on more or equal to 4 days during 1 week in the placebo run-in period (assessed at Visit 3).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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
8. Increased frequency and/or nocturia only due to renal or cardiac insufficiency known
from medical history
9. Neurological disorder associated with incontinence, e.g. Parkinson’s disease or Multiple Sclerosis, or influencing the bladder function
10. Urogenital surgery, e.g. surgical procedure for treatment of incontinence or prolapse,within the last 2 years
11. Known allergy or hypersensitivity to any components of the study medication or
structurally related drugs
12. Respiratory, renal (serum creatinine > 2.5 mg/dl or > 211 mmol/l), hepatic (ALAT > 3-fold ULN), gastrointestinal, haematological, endocrine, psychiatric or any other disease or condition that, in the opinion of the investigator, could affect the evaluation of the study medication
13. Obstructive disease of the gastrointestinal tract such as paralytic ileus, intestinal atony, megacolon (including toxic), chronic inflammatory bowel disease known from the
medical history
14. Any clinically significant heart disease
15. Known severe or malignant hypertension
16. Unstable diabetes that requires changes of the treatment with either insulin or other antidiabetic agents.
17. Any history of cerebral stroke.
18. Haematuria of unknown origin or haematuria secondary to malignant disease.
19. Interstitial cystitis (diagnosed by symptoms)
20. Previous participation in this study (participation in former cizolirtine studies is allowed)
21. Participation in another study of an investigational drug within the last 30 days prior to the screening visit or current participation in another study of an investigational drug.
22. Chronic alcohol or drug abuse within the last 6 months
23. Pregnant or nursing women, and women of childbearing potential not using reliable
contraceptive methods.
24. Any planned major surgery within the duration of the study.
25. Any other condition or symptoms preventing the subject from entering the study,
according to the investigator’s judgement.
26. Clinically relevant abnormal ECG as judged by the investigator.
Neither will the subject be included if one of the following criteria are fulfilled at the baseline visit:
27. Clinically relevant abnormal values from the laboratory tests on haematology, serum chemistry and urinalysis.
28. Initiated or changed pelvic floor muscle training within 2 months before the baseline visit or planned such therapy during the study.
29. Any treatment with clean intermittent self catheterisation or indwelling catheter within 2 weeks before baseline visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the efficacy of cizolirtine citrate 200 mg twice daily, 300 mg twice daily, and 400 mg twice daily versus placebo in decreasing the frequency of incontinence episodes.<br><br>;Secondary Objective: The secondary objectives are to<br>· evaluate the efficacy of cizolirtine citrate 200 mg twice daily, 300 mg twice daily, and 400 mg twice daily versus placebo with respect to secondary endpoints<br>· evaluate the dose-response relationship between cizolirtine 200 mg twice daily, 300 mg twice daily,and 400 mg twice daily for primary and secondary endpoints<br>· evaluate the change in subjective QoL experience of the treatment.<br>· evaluate the short term (12-week) safety;Primary end point(s): The primary efficacy endpoint is the change in frequency of incontinence episodes per 24<br>hours from baseline to last evaluable visit.