NCT01203371

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

September 15, 2010

Last Update Submit

February 7, 2023

Conditions

Hyperplasia

Keywords

naftopidilsymptoms of lower urinary tractbenign prostate hyperplasiaLUTS

Outcome Measures

Primary Outcomes (1)

  • International Prostate Symptom Score

    2, 4, 8 and 12 weeks

Secondary Outcomes (1)

  • Adverse Effect

    2, 4, 8 and 12 weeks

Study Arms (2)

Naftopidil

EXPERIMENTAL

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

Drug: Naftopidil

Tamsusolin

ACTIVE COMPARATOR

0,4 mg/day

Drug: Tamsulosin

Interventions

NaftopidilDRUG

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

Naftopidil
TamsulosinDRUG

0,4 mg/day

Also known as: SECOTEX
Tamsusolin

Eligibility Criteria

Age50 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men ≥ 50 years
  • Signs and symptoms of BPH
  • IPSS of ≥ 10
  • Prostate volume of ≥ 20 mL
  • PVR \> 150 mL

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

HyperplasiaProstatic Hyperplasia

Interventions

naftopidilTamsulosin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsProstatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 16, 2010

Study Start

January 1, 2011

Primary Completion

September 1, 2011

Study Completion

January 1, 2012

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

BR(1)