Overactive Bladder MedDRA version: 9.1 Level: LLT Classification code 10059617 Term: Overactive bladder
Conditions
Interventions
Product Name: Netupitant
Product Code: 14-NETU
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Netupitant
CAS Number: 290297-26-6
Current Sponsor code: Netupitant
Other descriptive name: NETU-
Sponsors
Helsinn Healthcare SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients = 18 years old 2. Symptoms of overactive bladder for at least 6 months before entering the run-in, single-blind treatment period 3. Able to read, understand and follow the study procedures and complete OAB diary 4. Willing and able to sign informed consent 5. If female, they must be either post-menopausal for at least 12 months or surgically sterilized. In case of fecund women, they must use a reliable method of contraception such as a combination of spermicidal / barrier method (condom, sponge, foam, jelly, or diaphragm) or intrauterine devices which do not involve the use of steroid hormones. 6. Baseline 3 day diary (to be recorded during the last three days before visit # 2), reporting = 3 urgency episodes, with or without = 3 incontinence episodes, and with 10-20 micturitions/24 hours 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. Breast feeding 2. Grade III/IV pelvic organ prolapse with or without cystocele 3. History of pelvic prolapse repair (cystocele or rectocele) or urethral diverticulectomy within 6 months of screening 4. Stress incontinence or mixed incontinence where the stress incontinence prevails 5. Urinary incontinence due to causes other than overactive bladder 6. Nocturnal enuresis only 7. Residual urinary volume > 200 ml measured by ultrasound 8. Current repeated Urinary Tract Infections (UTIs): > 4 episodes/year 9. Bladder cancer 10 History of unstable angina and/or congestive heart failure 11. History or predisposition to cardiac conduction abnormalities 12. History of risk factors for Torsade de Point (heart failure, hypokalemia, family history of Long QT Syndrome) 13. History of radiation cystitis or history of pelvic irradiation 14. Electro-stimulation, biofeedback, bladder training therapy (behavioral therapy) within 3 months of the screening visit and/or during the study 15. Investigational treatments within 30 days of start of run-in 16. Any neurological disease that may affect bladder function or muscle strength 17. Chronic alcohol or drug abuse 18. Diabetes insipidus 19. Diabetes mellitus type I or II with peripheral neuropathy and/or polyuria 20. Previous or concomitant local administration of botulinum toxin in the lower urinary tract 21.Chronic inflammatory bowel diseases such as Chron’s Disease and ulcerative colitis 22. Previous or concomitant treatment with NK1 receptor antagonists 23. Known contra-indications to NK1 receptor antagonists 24. Concomitant treatment with anti-muscarinic drugs. Patients on treatment with anti-muscarinic drugs and willing to participate will need to stop their administration from visit 1 throughout the study duration, including visit # 7. 25. Neoplastic disorder which is either active or has been in remission for less than one year 26. Chronic use of any CYP 3A4 substrates or inhibitors (e.g. terfenadine, cisapride, astemizole, clarythromycine, ketoconazole or itraconazole) (See appendix # 2, page 60 protocol) 27. Chronic use of any CYP 3A4 inducers (e.g. barbiturates, rifampicin, rifabutin, phenytoin, or carbamazepine) (See appendix # 2, page 60 protocol) 28. History or current diagnosis of HIV, or of any type of viral hepatitis 29. Concomitant use of a-blockers, a-adrenergic agonists, unless given at stable doses for at least 3 months of the screening visit and remaining stable throughout the study duration 30.Pregnancy 31. Polyuria (diuresis > 3 L/24 hours) 32. History of interstitial cystitis or bladder related pain 33. Any local pathology that might cause bladder symptoms 34. Severe, uncontrolled arterial hypertension or myocardial infarction 460 msec]; QRS > 110 msec; PR > 240 msec; HR 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy, safety and tolerability of three different, repeated oral doses of netupitant in patients with symptoms of OAB;Secondary Objective: ;Primary end point(s): Percentage change from the baseline in the average number of daily micturitions (primary) | — |
Countries
France, Germany
Outcome results
None listed