Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Intervention1: Fixed dose combination of
Silodosin 8 mg and Dutasteride
0.5 mg tablet in Capsule: One capsule taken orally daily
with a meal for 84 days (12
weeks).
Control Intervention1: Not Applicab
Sponsors
Optimus Pharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male confirmed BPH patients with radiological examination and estimated PSA levels at least six months before enrollment 2. All patients aged 45-80 years giving informed consent to participate in the study. 3. Patients with IPSS 4. Patients with enlarged prostate gland less than or equal to 30gm on either clinical examination or ultrasound Assessment (as available) 5. Patients with previously diagnosed BPH receiving Silodosin 8 mg and / or Dutasteride 0.5 mg as monotherapy or combination therapy as two individual tablets (to be substituted with the FDC) 6. Confirmed BPH patients with documented urine flow results available at screening not less than 10mL/Sec. 7. Patients willing to give informed consent for the study and willing to comply with all the study procedure and requirements.
Exclusion criteria
Exclusion criteria: 1. Unconfirmed and suspected cases of BPH 2. Confirmed cases of BPH with IPSS severity score 20 and above 3. Current severe urinary tract infections 4. Known allergy or contraindications to Silodosin and Dutasteride 5. History of syncope, and orthostatic hypotension 6. Bladder outlet obstruction due to cancer, calculi or stricture 7. Previous Transurethral Resection of the Prostate (TURP), 8. Any neurological disorders affecting storage and voiding functions, Prostatitis, PSA greater than 2.5 or higher in preceding 6 months 9. An episode of acute urinary retention within 4 weeks of study initiation, 10. Documented urinary tract infection, 11. Poorly controlled diabetes mellitus, 12. Poorly controlled hypertension. 13. Patients with mental disorders or illness who cannot understand or comply with the study protocol. 14. BPH with complications like CRF, hydronephrosis, acute bacterial prostatitis, hematuria. 15. Patients with LUTS and or bladder outlet obstruction due to causes other than BPH. 16. Patients taking nitrates for CYP3A4 inhibitors (ketoconazole, ritonavir) and CYP3A4 inducers (rifampicin). 17. Patients with previous history of prostate surgery, diagnosed cancer prostate. 18. Patients with severe cardiac, hepatic or renal insufficiency. 19. Patients with active untreated UTI, urolithiasis, PVR >200mls, patients in whom cystoscopy or biopsy has been done from urinary tract in the past 2 weeks urethral stricture disease, neurogenic bladder, prostate or urethral surgery, any previous history of continuous intermittent catheterization, h/o postural hypotension, patients with uncontrolled severe hypertension. 20. H/O treatment with verapamil, androgens, anti-androgens, diuretics, cholinergic, anticholinergics, phytotherapy in the past 3 months, 21. H/Oalcohol abuse, malignancy. 22. Patients with h/o any conditions exposing them to increased risk of adverse effects of silodosin including any serious life threatening cardiovascular, renal, neurological, hepatic. Any other disease or condition and any other systemic illness or disorder which in the clinical judgement 23. Patients who have participated in another investigational study within 30 days prior to screening in this study or planning to participate during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean change in Urine Peak Flow Rate (Qmax) 2. Reduction in bother based on the International prostrate Symptom Score (IPSS) 3. BPH impact Index self-assessment questionnaire on urinary problems (patient self-assessment questionnaire) 4. Improvement in QoL (questionnaire) (IPSS question on QoL)Timepoint: Day 0 (Visit 1), Day 30Ã?± 5 days (Visit 2), Day 60Ã?± 5 (Visit 3), Day 90Ã?± 5 days (Visit 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tolerance to the treatment and safety (assessment of adverse events and laboratory investigations) 2. Compliance to the treatment (patient rating)Timepoint: Day 0 (Visit 1), Day 30Ã?± 5 days (Visit 2), Day 60Ã?± 5 (Visit 3), Day 90Ã?± 5 days (Visit 4) | — |
Countries
India
Contacts
Public ContactVinayak Sargar
ClinVigilant Research Private Limited
Outcome results
None listed