A phase III Randomized Multicentric Open Label Active Controlled Parallel Comparative Study to Evaluate Efficacy and Safety of FDC of Silodosin 8mg and Solifenacin succinate 5mg Tablets in Comparison to Silodosin 8mg Tablets in Male Patients Having Benign Prostatic Hyperplasia (BPH)/Lower Urinary Tract Symptoms (LUTS) with Overactive Bladder(OAB) - NI

SAVI HEALTH SCIENCE0 sites0 target enrollmentStarted: TBDLast updated: August 19, 2024

Trial Snapshot

Phase: Phase 3
Status: Recruiting
Sponsor

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional

Eligibility Criteria

Inclusion Criteria

•1 Male patient aged between 50 to 75 years having Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms and with residual Overactive Bladder symptoms despite treatment with Silodosin 8 mg or other alpha blockers Alfuzosin 10 mg Tamsulosin 0.4 mg for more than equal to 4 weeks prior to screening
•2 Patient with International Prostate Symptom Score more than equal to 13 with urgency item score more than 1 during screening
•3 Patient with IPSS-QoL item score of greater than 2 during screening
•4 Patient with number of micturition more than equal to 8 times per 24 hours and at least 2 urgency episodes per 24 hours in a 3-day bladder diary during screening
•5 Patient with Post Void Residual volume less than equal to 150 ml and maximum urinary flow rate (Qmax) between 5 to 15 mL/s during screening
•6 Patient is willing to give informed consent
•7 Patient must agree to use adequate contraception from study entry till the last dose of the study medication

Exclusion Criteria

•1.Patient taking anti-muscarinics (other than Solifenacin) antispasmodics any substances to influence voiding function at the time of screening or planning to take during study
•2.Patient with history of prostate cancer and/or previous prostatic/ bladder neck surgery
•3 Patient with history of urethral obstruction due to stricture, valves, sclerosis or tumour and patient with previous urethral surgery
•4 Patient with autonomic neuropathy neurologic bladder conditions (multiple sclerosis spinal cord injury Parkinson disease)
•5.Patient with clinically significant bladder outflow obstruction other than BPH, as judged by investigator Patients receiving Miconazole
•6.Patient with chronic inflammation bladder stones bladder neck stricture sclerosis severe vesical diverticulum urethral stricture
•7.Patient with history of cancer or undergoing chemotherapy
•8.Patient with history of severe cardiac diseases including angina requiring certain treatment with nitrates or any clinically significant conditions
•9.Patient with a history of esophageal or intestinal or gastric pylorus obstruction or gastrointestinal disorders (including gastric retention and toxic megacolon) which is associated with decreased gastrointestinal motility at the time of screening
•10.Patient with hiatus hernia/gastro-oesophageal reflux and/or who is concurrently taking medicinal products (such as bisphosphonates) that can cause or exacerbate oesophagitis
•11.Patient with irradiation to the pelvis interstitial cystitis, prostatitis
•12.Patient who is likely to require catheterization within next 3 months
•13.Patient with history of symptomatic orthostatic hypotension or recurrent dizziness vertigo loss of consciousness or syncope
•14.Patient with history of any condition that is a contraindication for anticholinergic treatment including narrow angle glaucoma, urinary retention and myasthenia gravis
•15.Patient who started with a 5-alpha reductase inhibitor within 3 months prior to screening or planning to take during the study
•16.Patient undergoing haemodialysis
•17.Patient with symptomatic acute Urinary Tract Infection (UTI) during the screening period or recurrent UTI (more than equal to 2 episodes within the last 6 months from the screening).
•18.Patient with moderate to severe renal impairment (Creatinine clearance less than 50 mL/min) and severe hepatic impairment (AST and ALT more than 3 x ULN)
•19.Patient with serum Prostate Specific Antigen (PSA) beyond 4 ng/ ml at screening
•20.Patient with uncontrolled hypertension (BP more than equal to 140/90 mm of Hg) and type 2 diabetes (HbA1c more than 9%)
•21.Patient has a clinically significant disorder that in the opinion of the investigator would result in the patient’s inability to understand and comply with the requirements of the study
•22.Patient with history of HIV and/or Hepatitis B and/or Hepatitis C
•23.Patient with history of angioedema with airway obstruction
•24.Patient with rare hereditary problems of galactose intolerance the Lapp lactase deficiency or glucosegalactose malabsorption
•25.Patient planning cataract surgery during the study.
•26.Patients having history of QT prolongation or patients who are taking medications known to prolong QT interval
•27.Patient using any nitrates, androgens estrogens luteinizing hormone-releasing hormone (LH

Investigators

Sponsor

SAVI HEALTH SCIENCE

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