Health Condition 1: null- Indian male patients with lower urinary tract symptoms associated with benign prostatic hyperplasia.
Conditions
Interventions
Intervention1: Silodal (Silodosin 8mg): OD 12 weeks
Control Intervention1: nil: nil
Sponsors
Ranbaxy Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Outpatients aged 45 or over 2. Patients with a total I-PSS score of 13 or higher 3. Patients with a prostate volume measured by transabdominal ultrasonography or TRUS of >= 20 ml. 4. Patients with a maximum urinary flow rate (Qmax) of 4-15ml/sec (with voided urine volume >=125 ml).
Exclusion criteria
Exclusion criteria: 1. Patients with a residual urinary volume of >=250ml 2. Patients with a history of prostatectomy 3. Patients with PSA level > 4.0ng/mL 4. Patients with a history of intrapelvic radiation therapy 5. Patients with prostate cancer or suspected prostate cancer 6. Patients with complications considered likely to affect urinary passing such as neurogenic bladder, bladder calculus and active urinary tract infection. 7. Patients conducting self-catheterization 8. Patients with renal impairment 9. Patients with hepatic impairment. 10. Patients with history of severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months 11. Patients with a history of an allergy to α-blockers 12. Patients with orthostatic hypotension at around screening visit 13. Patients with an experience of other investigational product treatments within 4 weeks form screening visit. 14. Patients who have taken unstable doses of antidepressants within the 3 months or who are expected to take unstable doses during the study 15. Patients who have taken alpha blockers within the 2 weeks from the start of the therapy 16. Patients who have taken unstable doses of 5α-reductase inhibitors within the 3 months from the start of the therapy or who are expected to take unstable doses during the study. 17. Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with the assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, psychiatric, or hematological disease as determined by the clinical judgment of the investigator. 18. Any contra-indication to silodosin as mentioned in the prescribing information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change in BPH symptoms as assessed by changes in International Prostate Symptom Score (IPSS)Timepoint: over 12 weeks (at 3 days, 1 week, 4 weeks, and 12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Evaluation of Safety and tolerability by evaluating the incidence and severity of adverse events (AEs)Timepoint: all visits over the 12 weeks;change from baseline in QOL due to urinary symptomsTimepoint: 3 days, 1 week, 4 weeks and 12 weeks.;change in urinary flow rate measured by change from baseline in Qmax.Timepoint: 2 hours, 4 weeks, and 12 weeks;Evaluate the percentage of treatment responders achieving decrease in IPSS score from baseline of â?¥25%.Timepoint: 4 weeks, and 12 weeks;Evaluate the percentage of treatment responders achieving improvement in Qmax from baseline of â?¥30%.Timepoint: 4 weeks, and 12 weeks;improvement in voiding and storage symptoms by Percentage change in IPSS voiding and storage sub scoresTimepoint: 3 days, 1 week, 4 weeks and 12 weeks. | — |
Countries
India
Contacts
Public ContactDr chetan Mehndiratta
sponsor representative
Outcome results
None listed