Overactive bladder (OAB) MedDRA version: 12.1 Level: LLT Classification code 10059617 Term: Overactive bladder
Conditions
Interventions
Product Name: XEN-D0501
Product Code: XEN-D0501
Pharmaceutical Form: Coated tablet
Current Sponsor code: XEN-D0501
Other descriptive name: BAY 69-9426
Concentration unit: mg milligram(s)
Concentration
Sponsors
Xention Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of twice daily dosing with 2 doses of XEN-D0501 on the urinary symptoms of subjects with OAB compared to placebo.;Secondary Objective: To determine the safety and tolerability of twice daily dosing with 2 doses of XEN-D0501 in subjects with OAB compared to placebo.;Primary end point(s): Efficacy: Change from baseline to the last on-treatment evaluation visit in the number of voids/24hrs (mean of the three days prior to the last on-treatment visit). | — |
Countries
Belgium, Estonia, United Kingdom
Outcome results
None listed