Subjects with overactive bladder syndrome with urinary urge.
Conditions
Interventions
Product Name: NS-8
Product Code: APC-581
Pharmaceutical Form: Capsule, hard
CAS Number: 186033-14-7
Current Sponsor code: NS-8, APC-581
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
APOGEPHA Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjets with overactive bladder will be enrolled in this trial and randomised only if they meet all of the following criteria: 1. Are able to provide written informed consent; 2. Are minimum or older than 18 years of age; 3. Have at least 2 incontinence episodes within 3 days before Day 0; 4. Have at least 8 micturitions per 24 hours (mean of last 3 days before Day 0); 5. Females must not be pregnant or plan to become pregnant during the trial. Females with childbearing potential must provide a negative urine pregnancy test at Visits 1 and 2 and must be using an appropriate method of contraception 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: Patients will be enrolled in this trial only if they meet none of the following criteria: 1. Stress incontinence (involuntary loss of urine during coughing, sneezing, going upstairs or change of position); Note: A patient with mixed incontinence can be enrolled if urge incontinence is the predominant symptom of the patient's incontinence. 2. Intermittent catheterisation; 3. Neurogenic bladder dysfunction, spina bifida, quadriplegia, multiple sclerosis; 4. Benign prostatic hypertrophy syndrome with a significant degree of bladder outflow obstruction resulting in post-void residual urine =100 mL; 5. Females and males with post-void residual urine =100 mL; 6. Interstitial cystitis; 7. Single voided micturition volume >400 mL; 8. Mean volume per micturition within 24 hours >300 mL; 9. Mean voided volume >3 L within 24 hours; 10. Acute urinary tract infection within 7 days before and during randomisation proven by urinalysis and urine culture; 11. Chronic urinary tract infection (³105 bacteria/mL urine); 12. Electrostimulation therapy if performed within 4 weeks before Visit 1; 13. Anomalies of the lower genitourinary tract (e.g., fistulas, urethral or meatal stenosis, severe prolapse); 14. Radiation bladder, bladder calculi, urethral calculi, untreated bladder carcinoma; 15. Operations of the lower genitourinary tract within the last 6 months (e.g., Transurethral Prostatic Surgery [TUR-P] or total prostatectomy, bladder tumour operation, operative intervention for incontinence); 16. Have a progressive fatal disease/life expectancy of less than 5 years; 17. Have severe disease likely to jeopardise the planned completion of the trial (e.g., cancer, cardiac infarct, unstable angina pectoris); 18. Have impaired hepatic function 19. Diabetes insipidus; 20. Pre-existing medical contraindications for COX-inhibitors; 21. Tachyarrhythmia, hypotension; 22. Patients with QTc prolongation (QTc >500 ms) and patients with risk factors for QTc prolongation, e.g., cardiac insufficiency, hypokalaemia, congenital QT-long-syndrome as well as intake of medications with a potential to prolong the QTc interval; 23. History of, or known current problems with, drug or alcohol abuse; 24. Concomitant medication known to have a potential to interfere with the trial medication (see section 5.7.2); 25. Are likely to require treatment during the trial with drugs not permitted by the trial protocol (see section 5.7.2) 26. Known hypersensitivity to NS-8, oxybutynin or excipients contained in the trial medication; 27. Pregnant or nursing women, or women of childbearing potential without reliable contraceptive method; 28. History or suspicion of unreliability, poor co-operation or non-compliance with medical treatment; 29. Patients who are not able to swallow the largest capsule; 30. Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the trial; 31. Have received treatment with any other investigational drug in the last 30 days before Visit 1. 32. Have previously been enrolled in this trial. 33. Patients with contraindications to the use of oxybutynin; 34. Patients with untreated or suboptimally treated thyroid diseases manifested by clinically relevant abnormal blood concentrations of thyroid hormones (TSH, T3, thyroxine [T4]); 35. Patients with a history of sensitivity to photosensitising drugs (e.g., psoralen, tetracyclines, St. Johns Wort) displayed as photoallergies or phototoxicities; 36
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of 180 mg b.i.d. NS-8 versus placebo regarding primary efficacy variable (change in mean number of incontinence episodes within 3 days before Day 56 versus baseline).;Primary end point(s): Number of incontinence episodes within 3 days before Day 56, change versus baseline.;Secondary Objective: 1. Assessment of dose-relationship regarding primary efficacy variable. 2. Comparison of 240 mg b.i.d. NS-8 and 120 mg b.i.d. NS-8 versus placebo regarding primary efficacy variable; 3. Comparison of 180 mg b.i.d. NS-8, 240 mg b.i.d. NS-8 and 120 mg b.i.d. NS-8 versus active control regarding primary efficacy variable; 4. Comparison of efficacy of 120, 180 and 240 mg b.i.d. NS-8 versus placebo and active control regarding the secondary efficacy variables; 5. Comparison of safety and tolerability of NS-8 versus placebo and active control; 6. Assessment of variability and linearity of NS-8 trough levels in blood. | — |
Countries
Germany
Outcome results
None listed