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Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

Sponsor
Apsen Farmaceutica S.A. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01203371
Collaborator
(none)
250
Enrollment
1
Location
2
Arms
12
Duration (Months)
20.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of Naftopidil and Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of patients with benign prostatic hyperplasia.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Inclusion Criteria:

Men ≥ 50 years Signs and symptoms of BPH A total IPSS of ≥ 10 Prostate volume of ≥20 mL (estimated by ultrasonography) PVR > 150mL

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
PHASE III, DOUBLE-BLIND, RANDOMIZED STUDY COMPARING THE EFFICACY AND SAFETY OF NAFTOPIDIL AND TAMSULOSIN TO TREATMENT THE SYMPTOMS OF LOWER URINARY TRACT IN PATIENTS WITH BENIGN PROSTATE HYPERPLASIA
Study Start Date :
Jan 1, 2011
Anticipated Primary Completion Date :
Sep 1, 2011
Anticipated Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Naftopidil

0,25 mg (2 weeks) and 0,50 mg (10 weeks)

Drug: Naftopidil
0,25 mg (2weeks) and 0,50 mg (10 weeks)
Active Comparator: Tamsusolin

0,4 mg/day

Drug: Tamsulosin
0,4 mg/day
Other Names:
  • SECOTEX

    		•

    Outcome Measures

    Primary Outcome Measures

    1. International Prostate Symptom Score [2, 4, 8 and 12 weeks]

    Secondary Outcome Measures

    1. Adverse Effect [2, 4, 8 and 12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Men ≥ 50 years

    • Signs and symptoms of BPH

    • IPSS of ≥ 10

    • Prostate volume of ≥ 20 mL

    • PVR > 150 mL

    Exclusion Criteria:

    • History of allergy to a AR antagonists

    • Treatment with antiandrogen drugs

    • Drugs with anticholinergic activity

    • Significant history of orthostatic hypotension

    • Concomitant neurological diseases

    • Known or suspected neurogenic bladder dysfunction

    • Carcinoma of the prostate or bladder

    • Previous surgery for BPH or bladder neck obstruction

    • History of recurrent UTI

    • Concomitant active UTI

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital das Clínicas da Faculdade de Medicina da USP São Paulo Brazil 05403-010

    Sponsors and Collaborators

    • Apsen Farmaceutica S.A.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01203371
    Other Study ID Numbers:
    • APS 001/2010
    • BRA10APS001
    First Posted:
    Sep 16, 2010
    Last Update Posted:
    Sep 16, 2010
    Last Verified:
    Sep 1, 2010
    Keywords provided by , ,
    naftopidil
    symptoms of lower urinary tract
    benign prostate hyperplasia
    LUTS
    Additional relevant MeSH terms:
    Hyperplasia
    Naftopidil
    Tamsulosin

    Study Results

    No Results Posted as of Sep 16, 2010