Health Condition 1: N329- Bladder disorder, unspecified
Conditions
Interventions
Intervention1: Vibegron 75mg Tablet
: All patients who get into Test arm will receive Vibegron 75mg
Tablet once daily for 12 weeks
Control Intervention1: Mirabegron ER Tab 25mg: All patients who get i
Sponsors
MSN Laboratories Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Willing and able to provide written informed consent 2 Males or females greater than 18 years to less than 65 years of age 3 Patients must have a history of OAB as diagnosed by a physician for at least 3 months prior to the Screening Visit defined as urgency, with or without urge urinary incontinence UUI usually associated with frequency and nocturia Urodynamic evaluation is not required 4 Meets either the OAB Wet or OAB Dry criteria described below based on the Bladder Diary returned at Baseline Visit all Complete Diary Days must be used in determining eligibility A minimum of 4 complete diary days are required for the diary returned at the Baseline Visit OAB Wet Criteria An average of ³ 8 micturition per Diary Day and An average of ³ 1 UUI episodes per Diary Day and If stress urinary incontinence is present the total number of UUI episodes must be greater than the total number of stress urinary incontinence episodes from the previous visit diary OAB Dry Criteria An average of ³ 8 micturition per Diary Day and An average of ³ 3 urgency episodes per Diary Day and An average of less than 1.0 UUI episode per Diary Day and If stress urinary incontinence is present the total number of UUI episodes must be greater than the total number of stress urinary incontinence episodes from the previous visit diary 5 For females of reproductive potential: Agrees to remain abstinent or use or have their male partner use an acceptable method of birth control each time the patient has intercourse from the Screening Visit until completion of the Follow up Visit 6 For females of reproductive potential who agree not to donate ova eggs until at least 1 month after the last dose of Study Treatment 7 Is ambulatory and in good general physical and mental health as determined by the Investigator 8 In the opinion of the Investigator, is able and willing to comply with the requirements of the protocol including completing the questionnaires the Bladder Diary will require ability to collect measure and record voided volume by herself himself using a graduated urine collection and measurement container as provided by the Sponsor if needed
Exclusion criteria
Exclusion criteria: 1 Patient has a history of 24 hour urine volume greater than 3000 mL in the past 6 months or a Bladder Day measurement greater than 3000 mL during the Screening Period or after any necessary washout period 2 Has lower urinary tract pathology that could in the opinion of the Investigator be responsible for urgency frequency or incontinence including but not limited to urolithiasis interstitial cystitis prostate cancer gastrointestinal cancer tuberculosis stone disease urothelial tumour prostatitis and clinically relevant benign prostatic hypertrophy or bladder outlet obstruction as judged by the Investigator Note Male patients with mild to moderate BPH without evidence of bladder obstruction asdetermined by the Investigator may be included as long as they have been taking a medication for the treatment of BPH for at a least 1 year prior to Screening with no change in dose of herbal medications alpha antagonist medications or other symptomatic treatments or medications within 3 months prior to Screening and no change in dose of 5 alpha reductase inhibitors within 6 months of Screening 3 Has a history of surgery to correct stress urinary incontinence pelvic organ prolapses or procedural treatments for BPH within 6 months of Screening 4 Has current history or evidence of Stage 2 or greater pelvic organ prolapse 5 Patient is currently using a pessary for the treatment of pelvic organ prolapse 6 Has a known history of elevated post void residual volume defined as greater than 150 mL 7 Has undergone bladder training or electrostimulation within 28 days prior to Screening or plans to initiate either during the study 8 Has an active or recurrent greater than 3 episodes per year urinary tract infection by clinical symptoms or laboratory criteria greater than or equal to 5 white blood cells and or a positive urine culture defined as greater than or equal to 105 colony forming units CFU per mL in 1 specimen Patients diagnosed with a urinary tract infections at the Screening Visit may be treated and rescreened once the infection has resolved. 9 Has required for an indwelling catheter or intermittent catheterization 10 Has received an intradetrusor injection of botulinum toxin within 9 months prior to Screening 11 Has uncontrolled hyperglycemia defined as fasting blood glucose greater than 150 mg per dL or 8 point 33 mmol per L and or non fasting blood glucose greater than 200 mg per dL or 11point 1 mmol per L or if in the opinion of the Investigator is uncontrolled 12 Has evidence of diabetes insipidus 13 Is pregnant breast feeding or is planning to conceive within the projected duration of the study 14 Has a concurrent malignancy or history of any malignancy within 5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer 15 Has uncontrolled hypertension systolic blood pressure of greater than or equal to 180 100 mmHg or has a resting heart rate by pulse greater than 100 beats per minute 16 Has a history of cerebral vascular accident transient ischemic attack unstable angina myocardial infarction coronary artery interventions example coronary artery bypass grafting or percutaneous coronary interventions example angioplasty stent insertion or neurovascular interventions example carotid artery stenting) within 6 months prior to the Screening Vis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Change in average number of micturition per 24 hours in all OAB patients 2 change in average number of urge urinary incontinence episodes per 24 hours in OAB Patients Timepoint: 1 baseline to week 12 2 Baseline to week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Change in average number of urgency episodes need to urinate immediately over 24 hours in all OAB patients 2 Percent of OAB Wet patients with at least a 75% reduction 3 Percent of OAB Wet patients with a 100% reduction from 4 Percent of all OAB patients with at least a 50% reduction 5 change in average number of total incontinence episodes over 24 hours in OAB Wet patients 6 Change in Coping Score from the Overactive Bladder Questionnaire Long Form OAB-q 1week recall in all OAB patients 7 Change in average volume voided per micturition in all OAB patients 8 assessing the improvement in Overactive Bladder Symptoms Score Timepoint: 1 from Baseline to Week 12 2 from baseline in UUI episodes per 24 hours at Week 12 3 baseline in UUI episodes per 24 hours at Week 12 4 from baseline in urgency episodes need to urinate immediately per 24 hours a Week 12 5 from Baseline to Week 12 6 from Baseline to Week 12 7 from Baseline to Week 12 8 from Baseline to Week 12 | — |
Countries
India
Contacts
Public ContactChandu Devanpally
Ardent Clinical Research Services
Outcome results
None listed