A phase-III randomized open label active controlled multicenter study to evaluate the safety and efficacy of Vibegron 75 mg tablet in comparison with Mirabegron ER 25mg/50mg Tablet in Patients with Overactive Bladder (OAB)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 222
- 试验地点
- 11
研究概览
简要总结
A Phase III, randomized, open label, active controlled, multicenter study to evaluate the safety and efficacy of Vibegron 75 mg tablet, in comparison with reference product Mirabegron ER 25mg/50mg Tablet in Patients with Overactive Bladder (OAB). Approximately 222 men and women with overactive bladder will be enrolled at 8 to 10 study sites. At Baseline, patients who meet all eligibility criteria are randomized 1:1 ratio to receive either vibegron 75 mg, or Mirabegron ER 25mg/50mg Tablet in an open- label fashion. Between the Baseline and Week 12 Visits, patients will attend Visits at Week 2, week 4 and week 8.
This study consists of a Screening Period (2 weeks), a randomized Treatment Period (12 weeks), and a Safety Follow-up Period (2 weeks). Patients will have a Follow-up Visit approximately 14 days after the patient’s last dose of Study Treatment (i.e., at Week 14 for patients who complete the Week 12 Visit, or approximately 2 weeks after withdrawal for patients who discontinue the study early). Additionally, Unscheduled Visit(s) may be arranged for patients with study-related safety concerns as needed.Patients will be screened based on Demographics, Physical examination including vital signs (heart rate, blood pressure, body temperature, respiratory rate), past medical history, medication history, haematology, biochemistry, serology, Serum pregnancy test, Urine analysis, 12-lead ECG. On Day 0, the eligible patients will be randomized to receive one of the treatments arms tests drugs or active comparator group which will be administered for 12 weeks. End of study assessment will be performed at week 14. As per the Investigator’s opinion if there is a need to change the line of treatment for the patient then the patient will be withdrawn from the study and managed as per treating physician’s discretion. If any time during the study, the investigator performs any laboratory test as per his/her discretion the data will be captured in the source data. Adverse events (serious, non-serious, unexpected, expected, related, not related) will be monitored throughout the study period. The study will last approximately 12 weeks. The follow-up period will last for 14 days after the patient’s last dose under the study treatment (i.e. at week 12).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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 Visit Patients with these conditions should be on stable medical therapy for at least 3 months prior to the Screening Visit.
- •17 Has a history of injury surgery or neurodegenerative diseases example multiple sclerosis Parkinsons that could affect the lower urinary tract or its nerve supply 18 Has hematuria including microscopic hematuria greater than 5 red blood cells rbcS per HPF 19 Patients with known fully evaluated benign haematuria may participate 20 Has clinically significant electrocardiogram abnormality that in the opinion of the Investigator exposes the patient to risk by participating in the study 21 Has a known history of liver disease Has alanine aminotransferase or aspartate aminotransferase greater than 2 point 0 times the upper limit of normal or bilirubin total Bilirubin greater than 1 point 5 X ULN or greater than 2 point 0 X ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome 22 Has clinically significant laboratory abnormality from the Screening Visit results that remains unresolved after repeat testing or that could confound the results of the study or indicate that it is not in the best interest of the patient to participate 23 Has an estimated glomerular filtration rate eGFR less than 30 mL per min per 1 point 73 m2 24 Use of any prohibited medications as detailed in Prohibited Medication and Non Drug therapies suitable washout periods from these medications are also described therein 25 Has an allergy intolerance or a history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of the Vibegron and or the Mirabegron ER 25mg per 50mg Tablet formulation 26 Is currently participating or has participated in a study with an investigational compound or device within 28 days prior to signing informed consent 27 Has a history of significant drug or alcohol abuse dependence within a year prior to informed consent as assessed by the investigator 28 Has coronary or neurovascular interventions planned during the duration of the study 29 Has a history or current evidence of any condition therapy lab abnormality or other circumstance that might in the opinion of the Investigator confound the results of the study interfere with the patients ability to comply with study procedures or make participation in the study not in the patients best interest.
研究者
K Ravinder Reddy
MSN Laboratories Private Limited