A Phase 2a, multicentre, parallel-group, randomised, double-blind, placebo-controlled study to evaluate the safety and efficacy of 2 doses of XEN-D0501 in the treatment of idiopathic overactive bladder (OAB).
- Conditions
- Overactive bladder (OAB)MedDRA version: 12.1Level: LLTClassification code 10059617Term: Overactive bladder
- Registration Number
- EUCTR2010-022611-19-BE
- Lead Sponsor
- Xention Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 300
1. Willing and able to give written, informed consent
2. Females, 40-80 years of age. If under 60 years of age, subjects must not be of child bearing potential (i.e., postmenopausal [defined as amenorrheic for at least 1 year (off hormone replacement therapy) AND have a serum follicle-stimulating hormone (FSH) level of at least 30 IU/L at Visit 1], or have undergone a hysterectomy or bilateral oophorectomy, or have other documented evidence of infertility. Note: Tubal ligation is not acceptable)
3. A current primary diagnosis of OAB (in accordance with International Continence Society [ICS] guidelines) with medical history indicating a mean of = 8 voids/day and 1 or more episodes of urgency or incontinence/day
4. Evidence of frequency in combination with moderate to severe urgency episodes from the Placebo Run-in Period micturition diary, with a mean of = 8 voids/day and a total of =3 episodes of moderate to severe urgency or incontinence during the 3 day urinary diary period before randomisation at Visit 2
5. Body mass index (BMI) between 18 and 32 kg/m2
6. Agree to refrain from blood donation during the course of the study
7. Agree to stop taking any existing medication that may interfere with study evaluation (e.g. diuretics, antimuscarinics, potent CYP3A4 inhibitors and antidepressants) from the start of Placebo Run-in Period to the final Follow-up Visit.
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. Clinically significant unstable medical condition (other than idiopathic OAB) that might in the Investigator’s opinion interfere with assessment or follow-up
2. History or evidence of urinary retention or bladder outlet obstruction (defined as post-void residual volume >50mL or uroflow rate <15mL/sec with a void volume at least 120 ml)
3. Current (within past 3 months) bladder pain
4. History of QTc prolongation or QTc interval =470 msec at Visit 1
5. Predominant stress urinary incontinence versus urge urinaryincontinence based on subject history (e.g. exclude patients whose predominant symptoms are incontinence related to cough, sneezing, straining, etc.)
6. Neurogenic bladder (e.g. associated with spinal cord injury, multiple sclerosis)
7. Anatomic or structural abnormalities possibly causing urinary urgency or incontinence
8. Surgery on the lower urinary tract within previous 3 months of the baseline assessment (Visit 1)
9. History of =4 urinary tract infections (UTIs), interstitial cystitis or haematuria of unknown cause, or use of indwelling catheter in the previous 12 months or a current diagnosis of UTI as determined by the investigator;
10. Electro-stimulation therapy or starting bladder training or physiotherapy for bladder control within previous 2 weeks of Visit 1
11. Scheduled surgery or procedure during the study period
12. History (within previous 1 year of consent) of alcohol or substance dependence (except nicotine dependence) according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV TR) criteria
13. History of any kind of cancer within the last 5 years unless non-invasive, in remission and approved in writing by Sponsor
14. Existing non-malignant tumours that could compromise the function and/or anatomy of the lower urinary tract
15. Urine output >3.0L/day
16. Concomitant disease or condition (or its treatment) which could interfere with the conduct of the study, or which would in the opinion of the Investigator, pose a risk to the subject in this study
17. Participation in an investigational drug or device study within 30 days prior to Visit 1 or within 5 half lives of the drug, whichever is the greater.
18. Botulinum toxin treatment within previous 9 months of Visit 1
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