A clinical trial to study the effects of two drugs, naftopidil and tamsulosin in patients with benign prostatic hyperplasia.

Phase 3

Completed

• Registration Number: CTRI/2009/091/000964
• Lead Sponsor: Sun Pharmaceutical Industries Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Male patients aged between 50-80 years.
2.Patients with diagnosis of BPH.
3.Patients with IPSS total score of ≥8
4.Patient willing to give their informed consent

Exclusion Criteria

1.Patients having history of allergy to Alpha1 - adrenoceptor antagonists.
2.Patients on treatment with antiandrogen drugs.
3.Patients on current therapy with any Alpha1 - adrenoceptor antagonist.
4.Patients taking any drug with anticholinergic activity.
5.Patients with significant history of orthostatic hypotension.
6.Patients with concomitant neurological diseases, known or suspected neurogenic bladder dysfunction.
7.Patients with carcinoma of the prostate or bladder previous surgery for BPH or bladder neck obstruction.
8.Patients with history of recurrent UTI or Concomitant active UTI.
9.Patients who have serious mental illness.
10.Patient who have serious disorder with respect to cerebral blood vessels.
11.Patients who are taking drugs, which have phosphodiesterese 5 inhibitory action

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Evaluation of change in Total International Prostate Symptom Score.<br>2.Evaluation of change in Total IPSS storage score.<br>3.Evaluation of change in Total IPSS voiding score.<br><br>Timepoint: Time Points: Baseline Visit (day 0), week 2, week 4, week 6 and week 12.<br>

Secondary Outcome Measures

Name	Time	Method
1.Evaluation of change from baseline in individual IPSS Score. <br>2.Evaluation of change from baseline in Quality of Life (QOL) Index score. <br>3.Clinical Global Impression on Improvement (CGI-I) in patients <br>Timepoint: Time Points: <br>1.Baseline Visit (day 0), week 2, week 4, week 6 and week 12.<br>2.Time Points: Baseline Visit (day 0), week 2, week 4, week 6 and week 12.<br>3.Time Points: Week 2, week 4, week 6 and week 12.