Phase III clinical trial for Evaluation of Efficacy and Safety of IN-ALRN-001 in Comparison with Tamsulosin in Patients with lower urinary tract symptoms associated with BPH.

Phase 3

Completed

• Conditions: Health Condition 1: null- Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hypertrophy (BPH)

• Registration Number: CTRI/2009/091/000742
• Lead Sponsor: Intas Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1. Ambulatory males (≥50 years) suffering from LUTS (IPSS score 7) secondary to diagnosed BPH (Prostate volume 50 ml, by ultrasound)

2. Patient or his legally accepted representative is willing to provide written informed consent

Exclusion Criteria

1. Neurogenic disorder, UTI, recent history of urinary retention, bladder stone or bladder tumor
2. Serum Prostate Specific Antigen (PSA) > 10 ng/ml
3. Uninvestigated hematuria
4. Serious cardiovascular diseases
5. Hypertension patients treated with other α1-blockers
6. History of postural hypotension or syncope
7. Hepatic insufficiency (AST/ALT ≥ 2.5 x ULN) or Renal insufficiency (serum creatinine ≥ 1.5 x ULN)
8. Clinically significant abnormalities on physical examination or laboratory tests
9. Ongoing use of prohibited medications

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in IPSS total scoreTimepoint: Baseline, 2 weeks and the end of treatment

Secondary Outcome Measures

Name	Time	Method
Change in the following at the endpoint from baseline: <br/ ><br>1. Voiding symptoms subscore (IPSS) - intermittency, weak stream and straining <br/ ><br>2. Storage symptoms subscore (IPSS) - frequency, urgency and nocturia <br/ ><br>3. Quality of life index score (IPSS) <br/ ><br>4. Qmax, Qave and VT measured by uroflowmetry <br/ ><br>5. Post void Residual Urine VolumeTimepoint: 1. Baseline, 2 weeks and the end of treatment <br/ ><br> <br/ ><br> <br/ ><br>2. Baseline, 2 weeks and the end of treatment <br/ ><br> <br/ ><br> <br/ ><br>3. Baseline, 2 weeks and the end of treatment <br/ ><br> <br/ ><br>4. Baseline, 2 weeks and the end of treatment <br/ ><br> <br/ ><br>5. Baseline and the end of treatment <br/ ><br>