A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Prospective Study to Assess the Efficacy, Safety and Tolerability of Three Oral Doses of Netupitant Given Once a Day (50, 100 and 200 mg) vs Placebo in Patients with Overactive Bladder.
- Conditions
- Overactive BladderMedDRA version: 9.1Level: LLTClassification code 10059617Term: Overactive bladder
- Registration Number
- EUCTR2008-003190-41-FR
- Lead Sponsor
- Helsinn Healthcare SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
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
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)
27. Chronic use of any CYP 3A4 inducers (e.g. barbiturates, rifampicin, rifabutin, phenytoin, or carbamazepine)
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 < 3 months, congestive heart failure, active coronary artery disease
35. Use of concomitant medications that prolong the QT/QTc interval
36. History of any illness that, in the opinion of the investigator, may confound the results of the study or pose unwarranted risk in administering the study drug to the patient
37. Concomitant diseases likely to interfere with the study drug (capable of altering absorption, metabolism or excretion
38. Marked baseline prolongation of QT/QTc interval [QTc >460 msec]; QRS > 110 msec; PR > 240 msec; HR < 55 bpm; atrial fibrillation; complete left bundle branch block. For this purpose, the ECG performed at screening visit will be assessed.
39. Abnormal laboratory values including:
a. AST (Aspartate Aminotransferase) > 2.5 x Upper Limit of Normal
b. ALT (Alanine Aminotransferase) > 2.5 Upper
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method