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.

An Open Label, Randomized, Parallel Group, Prospective, Multicenter 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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000742

Enrollment

200

Registered

2009-12-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: IN-ALRN-001: 50 mg once daily for 4 weeks Control Intervention1: Tamsulosin Hydrochloride: 0.2 mg once daily for 4 weeks

Eligibility

Inclusion criteria

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

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 &#945;1-blockers 6. History of postural hypotension or syncope 7. Hepatic insufficiency (AST/ALT &#8805; 2.5 x ULN) or Renal insufficiency (serum creatinine &#8805; 1.5 x ULN) 8. Clinically significant abnormalities on physical examination or laboratory tests 9. Ongoing use of prohibited medications

Design outcomes

Primary

Measure	Time frame
Change in IPSS total scoreTimepoint: Baseline, 2 weeks and the end of treatment	—

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr Mudassar Mor

Medical Advisor

mudassar_mor@intaspharma.com66523442

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026