None listed
Conditions
Interventions
Intervention1: Naftopidil tablets: 25 mg once daily after meals for 12 weeks
in those patients in whom the response is unsatisfactory, the dosage can be increased to 50mg - 75mg once day gradually, after 1-2 weeks
Control Intervention1: Tamsulosin capsules: 0.4 mg once daily f
Sponsors
Sun Pharmaceutical Industries Ltd.
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Evaluation of change in Total International Prostate Symptom Score. 2.Evaluation of change in Total IPSS storage score. 3.Evaluation of change in Total IPSS voiding score. Timepoint: Time Points: Baseline Visit (day 0), week 2, week 4, week 6 and week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Evaluation of change from baseline in individual IPSS Score. 2.Evaluation of change from baseline in Quality of Life (QOL) Index score. 3.Clinical Global Impression on Improvement (CGI-I) in patients Timepoint: Time Points: 1.Baseline Visit (day 0), week 2, week 4, week 6 and week 12. 2.Time Points: Baseline Visit (day 0), week 2, week 4, week 6 and week 12. 3.Time Points: Week 2, week 4, week 6 and week 12. | — |
Countries
India
Contacts
Public ContactDr. Surendra Borgharkar
Outcome results
None listed