CTRI/2022/12/048058已完成3 期
A Multicenter, Randomized, Open-label, Parallel Group, Active Control, Phase III Study to Evaluate the Efficacy, Safety of Fixed Dose Combination of Silodosin 8 mg and Mirabegron 25/50 mg Tablets Versus Silodosin 8 mg Co-administered with Mirabegron 25/50 mg Tablets as Add-on Therapy in Adult Patients Diagnosed with Benign Prostatic Hyperplasia complicated by overactive bladder with Symptoms of Urge Urinary Incontinence, Urgency, and Frequency
M/s. Windlas Biotech Limited0 个研究点目标入组 240 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male subjects aged 45 to 65 years (both inclusive) with confirmed diagnosis of Benign Prostatic Hyperplasia complicated by overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency (including micturitions greater than or equal to8 per day and urinary urgency episodes greater than or equal to per day).2. Subjects willing to give voluntary their written informed consent to participate in the study before being screened for the study.3. Able to adhere to study visit schedule and other protocol requirements.
排除标准
- •1. Subject having a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction
- •2. Subject having Urinary retention requiring catheterization
- •3. Subject having symptomatic, untreated urinary tract infection not resolved prior to starting of investigational products
- •4. Subject taking Botulinum toxin injection for Urgency Urinary Incontinence UUI in the last year
- •5. Current therapy with peripheral or sacral neuromodulation
- •6. Neurologic conditions that may affect urinary function like stroke,multiple sclerosis, spinal cord injury, Parkinsons disease
- •7. Subjects 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
- •8. Subjects with severe renal insufficiency or ongoing or planned dialysis.
- •9. Subjects 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 times ULN accompanied by AST greater than ULN assessed at screening
- •and or Child Pugh Class C
- •10. Serum AST and or ALT greater than 3 times ULN assessed at screening
- •11. Men who are unwilling to use contraception while receiving investigational product
- •12. Known or suspected hypersensitivity to investigational products or any other component of the formulation
- •13. Failure to control systemic fungal, bacterial or viral infection
- •14. Known human immunodeficiency virus HIV or hepatitis B or C classes of active viral infection
- •15. Subjects with suspected signs and symptoms of COVID19 or confirmed novel coronavirus infection COVID19 or with a
- •recent history of travel or contact with any COVID19 positive subject or isolation or quarantine in the last 14 days
- •16. Have a history of neurological or psychiatric disorders, including epilepsy or dementia
- •17. According to the investigators judgment, there are concomitant diseases with a serious safety hazard or affect the subjects
- •participation in the study in subjects
- •18. Using other experimental drugs or participating in other clinical trials in the prior one month
- •19. Concomitant life-threatening disease with a life expectancy less than 12 months
- •20. Any factor or condition likely to affect protocol compliance of the subject as judged by the investigator
研究者
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