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Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

Primary Purpose

Hyperplasia

Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Naftopidil
Tamsulosin
Sponsored by
Apsen Farmaceutica S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperplasia focused on measuring naftopidil, symptoms of lower urinary tract, benign prostate hyperplasia, LUTS

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das Clínicas da Faculdade de Medicina da USP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Naftopidil

Tamsusolin

Arm Description

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

0,4 mg/day

Outcomes

Primary Outcome Measures

International Prostate Symptom Score

Secondary Outcome Measures

Adverse Effect

Full Information

First Posted
September 15, 2010
Last Updated
February 7, 2023
Sponsor
Apsen Farmaceutica S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01203371
Brief Title
Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS
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 Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Study Start Date
January 1, 2011 (Actual)
Primary Completion Date
September 1, 2011 (Actual)
Study Completion Date
January 1, 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Apsen Farmaceutica S.A.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperplasia
Keywords
naftopidil, symptoms of lower urinary tract, benign prostate hyperplasia, LUTS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naftopidil
Arm Type
Experimental
Arm Description
0,25 mg (2 weeks) and 0,50 mg (10 weeks)
Arm Title
Tamsusolin
Arm Type
Active Comparator
Arm Description
0,4 mg/day
Intervention Type
Drug
Intervention Name(s)
Naftopidil
Intervention Description
0,25 mg (2weeks) and 0,50 mg (10 weeks)
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
SECOTEX
Intervention Description
0,4 mg/day
Primary Outcome Measure Information:
Title
International Prostate Symptom Score
Time Frame
2, 4, 8 and 12 weeks
Secondary Outcome Measure Information:
Title
Adverse Effect
Time Frame
2, 4, 8 and 12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina da USP
City
São Paulo
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS

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