study to evaluate the effectiveness and safety of Silodal (silodosin) in Indian male patients with lower urinary tract symptoms
- Conditions
- Health Condition 1: null- Indian male patients with lower urinary tract symptoms associated with benign prostatic hyperplasia.
- Registration Number
- CTRI/2014/03/004463
- Lead Sponsor
- Ranbaxy Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 250
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).
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.