A Multicenter, Randomized, Open-label, Parallel Group, Active Control, Phase III Study to Evaluate the Efficacy, Safety of Fixed Dose Combination of Mirabegron (ER) 25 mg/50 mg + Tamsulosin (MR) 0.4 mg/0.4 mg Tablets Versus Fixed Dose Combination of Mirabegron (ER) 25 mg and Silodosin 8mg Tablets in Adult Male Patients Diagnosed with Benign Prostatic Hyperplasia with Overactive Bladder with Lower Urinary Tract Symptoms
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 222
- 试验地点
- 10
- 主要终点
- Change in Total Overactive Bladder Symptom Score (OABSS) with a clinically effective improvement defined as a reduction of greater than or equal 3 points from baseline to week 12
研究概览
简要总结
This is an randomized, open label, prospective, multi-center, three arms, active control study.
During Screening (Visit 1), participants who require treatment with Mirabegron and Tamsulosin will be assessed. Each participant will be given a diary card to record data for three consecutive days. The information collected from the diary card will be used to determine eligibility as per predefined criteria for the study. If participants meet all eligible criteria will be enrolled into the study. On day of Randomization (visit 2), Eligible 222 participants (74 per arm) will be randomized in a 1:1:1 ratio into one of the three groups. Participants will receive treatment orally once daily for 12 weeks either with the FDC of Mirabegron (ER) 25 mg and Tamsulosin (MR) 0.4 mg tablets or FDC of Mirabegron 50 mg and Tamsulosin (MR) 0.4 mg tablets of Windlas Biotech Limited or FDC of Mirabegron (ER) 25 mg and Silodosin 8mg Tablet.
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
- 45.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Male participants aged 45 to 75 years (both inclusive) with confirmed clinical diagnosis of Benign Prostatic Hyperplasia (BPH) which is defined as having the following features: (A)Moderate to severe lower urinary tract symptoms (LUTS) with International Prostate Symptom Score (IPSS) greater than 8 and (B)maximum urinary flow rate less than 15 mL per s.
- •2.Participants with BPH complicated by overactive bladder with lower urinary tract symptoms (LUTS) (urinary frequency and urgency with or without incontinence) despite treatment with Silodosin 4 mg or other alpha blocker Tamsulosin 0.4 mg for more than equal to 4 weeks prior to screening.
- •3.Participant with number of micturition grater than or equal 8 times per 24 hours and at least 2 urgency episodes per 24 hours with or without incontinence in a 3day bladder diary during screening.
- •4.Participant with Post Void Residual volume less than equal to 150 ml and maximum urinary flow rate (Qmax) between 5 to 15 mL per s during screening.
- •5.Participant has Prostate Specific Antigen (PSA) less than4 ng per mL or greater than or equal 4 but less than 10 ng per mL with a prostate biopsy that is negative for cancer in the past 2 years.
- •6.Participants willing to give voluntarily their written informed consent to participate in the study before being screened for the study.
- •7.Able to adhere to study visit schedule and other protocol requirements.
- •8.Participants agrees not to participate in another trial while on treatment.
排除标准
- •1.Participant having a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction.
- •2.Participant with clinically significant bladder outflow obstruction other than BPH (except large median lobe) due to calculi, tumor or stricture.
- •3.Participant having Urinary retention requiring catheterization.
- •4.Participant having symptomatic, untreated urinary tract infection not resolved prior to starting of investigational products.
- •5.Participants with Uncontrolled Diabetes having HbA1c value of greater than 8.0 percentage.
- •6.Participant taking Botulinum toxin injection for Urgency Urinary Incontinence (UUI) in the last year.
- •7.Current therapy with peripheral or sacral neuromodulation.
- •8.Neurologic conditions that may affect urinary function (stroke, multiple sclerosis, spinal cord injury, Parkinsons disease).
- •9.Participants with significant cardiac disorder (e.g., cardiac valve disease requiring a specific treatment, pericardial constriction, Life-threatening arrhythmia, uncontrolled hypertension, Acute myocardial infarction, permanent atrial fibrillation).
- •10.Participants with severe renal insufficiency or ongoing or planned dialysis.
- •11.Participants with documented severe hepatic impairment (with or without cirrhosis) according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin greater than 3 x ULN accompanied by AST greater than ULN (assessed at screening) and or Child Pugh Class C.
- •12.Serum AST and/or ALT greater than 3 x ULN (assessed at screening).
- •13.Men who are unwilling to use contraception while receiving investigational product.
- •14.Known or suspected hypersensitivity to investigational products or any other component of the formulation.
- •15.Failure to control systemic fungal, bacterial or viral infection.
- •16.Known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection.
- •17.Have a history of neurological or psychiatric disorders, including epilepsy or dementia.
- •18.According to the investigators judgment, there are concomitant diseases with a serious safety hazard or affect the participants participation in the study.
- •19.Using other experimental drugs or participating in other clinical trials in the prior one month.
- •20.Concomitant life-threatening disease with a life expectancy less than 12 months.
- •21.Any factor or condition likely to affect protocol compliance of the participant as judged by the investigator.
结局指标
主要结局
Change in Total Overactive Bladder Symptom Score (OABSS) with a clinically effective improvement defined as a reduction of greater than or equal 3 points from baseline to week 12
时间窗: Change in Total Overactive Bladder Symptom Score (OABSS) with a clinically effective improvement defined as a reduction of greater than or equal 3 points from baseline to week 12 | Change in International Prostate Symptom Score (IPSS) score with a clinically effective improvement defined as a reduction of greater than or equal 3 points from baseline to week 12
Change in International Prostate Symptom Score (IPSS) score with a clinically effective improvement defined as a reduction of greater than or equal 3 points from baseline to week 12
时间窗: Change in Total Overactive Bladder Symptom Score (OABSS) with a clinically effective improvement defined as a reduction of greater than or equal 3 points from baseline to week 12 | Change in International Prostate Symptom Score (IPSS) score with a clinically effective improvement defined as a reduction of greater than or equal 3 points from baseline to week 12
次要结局
- •Number of Micturitions Per 24 Hours at week 4, week 8 and week 12 and compare to baseline(Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI)).(•Number of micturition Urgency Episodes per 24 Hours at week 4 and week 8 and week 12)
研究者
Dr Antaryami Maharana
Abiogenesis Clinpharm Private Limited