Health Condition 1: N33- Bladder disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: FDC of Silodosin 8 mg and Solifenacin Succinate 5 mg Capsule: Patient in both the arms will be asked to consume two capsules as a whole (of FDC of Silodosin and Solifenacin Succinate Ca
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male patient, aged between 50 to 75 years (both inclusive), having Benign Prostatic Hyperplasia (BPH)/ Lower Urinary Tract Symptoms (LUTS) and with residual Over Active Bladder (OAB) 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 total IPSS 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 micturitions 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 (PVR) 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
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 (e.g. multiple sclerosis, spinal cord injury, Parkinson disease) 5) Patient with clinically significant bladder outflow obstruction other than BPH, as judged by investigatorPatients 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 patientâ??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 glucose-galactose 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, lu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in IPSS Storage subscore from baselineTimepoint: [Time frame: 4, 8 and 12 weeks] | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in IPSS Voiding (Obstructive) subscore from baselineTimepoint: [Time frame: 4, 8 and 12 weeks];Change in IPSS- QoL from baselineTimepoint: [Time frame: 4, 8 and 12 weeks];Change in mean number of micturitions per 24 hrs from baselineTimepoint: [Time frame: 4, 8 and 12 weeks];Change in mean number of urgency episodes per 24 hrs from baselineTimepoint: [Time frame: 4, 8 and 12 weeks];Change in post void residual volume from baselineTimepoint: [Time frame: 12 weeks];Change in Total International Prostate Symptom Score (IPSS) from baselineTimepoint: [Time frame: 4, 8 and 12 weeks] | — |
Countries
India
Contacts
Public ContactGuruprasad Palekar
Sun Pharma laboratories Limited
Outcome results
None listed