Health Condition 1: N33- Bladder disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: FDC of Mirabegron (ER) 25 mg and Tamsulosin (MR) 0.4 mg tablet
FDC of Mirabegron (ER) 50 mg and Tamsulosin (MR) 0.4 mg tablet: FDC Mirabegron (ER) 25 mg and Tamsulosin (MR) 0.4 mg tabl
Sponsors
M/s. Windlas Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 12Timepoint: 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Number of UUI Episodes Per 24 Hours at week 4 and week 8 and week 12 in the subgroup of participants with Incontinence categorised as OAB-wet Number of Nighttime Micturitions Per 24 Hours at week 4 and week 8 and week 12Timepoint: baseline to 24 hours, 4 weeks, 8 weeks and 12 weeks | — |
Countries
India
Contacts
Public ContactMr Prashant Dabral
Abiogenesis Clinpharm Private Limited
Outcome results
None listed