CTRI/2019/12/022231CompletedPhase 4
A Randomized, prospective, open-label, Active controlled, multi-center, post-marketing study to evaluate the efficacy and safety of Silodal (silodosin) vs Tamsulosin in Indian male patients with lower urinary tract symptoms associated with benign prostatic hyperplasia.
Sun Pharma Industries Ltd0 sites246 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 246
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Pms
Eligibility Criteria
Inclusion Criteria
- •1.Male patients, aged 45 to 75 years.
- •2.Patients with a total AUASS 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) <10 ml/sec (with voided urine volume >=125 ml).
- •5.Patients, who have been diagnosed with BPH through digital rectal exam.
- •6.PSA lesser than 4 ng/ml.
- •7.Patient or his legally accepted representative is willing to give informed consent.
Exclusion Criteria
- •1.Patients with a residual urinary volume of >=250 ml.
- •2.Patients with a history of prostatectomy.
- •3.Patients with a history of intra pelvic radiation therapy.
- •4.Patients with prostate cancer or suspected prostate cancer.
- •5.Patients with complications considered likely to affect urinary passing such as bladder calculus and active urinary tract infection.
- •6.Patients conducting self-catheterization.
- •7.Patients who are active on catheterization.
- •8.Patients with renal impairment. Patients having out of normal ranges values for, BUN test-normal result is generally 6 to 20 mg/dL, Creatinine Blood -normal result is 0.7 to 1.3 mg/dL for men, Creatinine Urine-14 to 26 mg per kg of body mass per day for men, Creatinine Clearance-Male: 97 to 137 ml/min.
- •9.Patients with hepatic impairment-Severe hepatic impairment (Child-Pugh score >= 10).
- •10.Patients having point of median lobe protruding more than 1 cm
- •11.Patients with history of severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months.
- •12.Patients with orthostatic hypotension at around screening visit (Orthostatic hypotension is defined as a decrease in systolic blood pressure of 20 mmHg or a decrease in diastolic blood pressure of 10 mmHg within three minutes of standing when compared with blood pressure from the sitting or supine position). 13
- •13.Patients with an experience of other investigational product treatments within 4 weeks from 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 any other α-blockers within the 2 weeks from the start of the therapy.
- •16.Patients who have taken unstable doses of any other 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 study drugs as mentioned in the prescribing information.
- •19.Intravesical obstruction from any cause other than BPH including vesicle neck contracture, Mullerian duct cysts, urethral stricture, valves, sclerosis, or other urethral tumor.
- •20.History of, or current neurogenic bladder and other conditions that might affect bladder function including detrusor-sphincter dyssynergia, prior CVA, spinal cord injury, brain or spinal cord tumors, multiple sclerosis, diabetic neuropathies, prior transient ischemic attacks, or dementia.
- •21.History of any type of procedure in the past that was considered intervention for BPH or bladder neck obstruction including prior TURP, bladder neck resection, thermotherapy, laser therapy, TUNA therapy, or any other minimally invasive surgical therapies specifically designed for relief of BPH.
- •22.History of inadequate clinical response to the use of alpha blockers specifically for the relief of BPH symptoms.
Investigators
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