Stress Urinary Incontinence
Conditions
Interventions
Product Name: Cizolirtine citrate
Product Code: Cizolirtine citrate
Pharmaceutical Form: Tablet
INN or Proposed INN: cizolirtine citrate
CAS Number: 142155-44-0
Current Sponsor code: E-4018
Concentrat
Sponsors
Laboratorios Dr. Esteve, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Secondary Objective: The secondary objectives are to · 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 · 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 · evaluate the change in subjective QoL experience of the treatment. · 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 hours from baseline to last evaluable visit. | — |
Countries
Czech Republic, Estonia, Spain, Sweden
Outcome results
None listed