Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

February 7, 2023 updated by: Apsen Farmaceutica S.A.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-010
        • Hospital das Clínicas da Faculdade de Medicina da USP
        • Contact:
          • Geraldo C Freire, PhD
          • Phone Number: 55 11 3069-8082
        • Contact:
        • Principal Investigator:
          • Geraldo C Freire, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
International Prostate Symptom Score
Time Frame: 2, 4, 8 and 12 weeks
2, 4, 8 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Effect
Time Frame: 2, 4, 8 and 12 weeks
2, 4, 8 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apsen Farmaceutica S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2011

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (ESTIMATE)

September 16, 2010

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APS 001/2010
  • BRA10APS001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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