Last updated: 05/24/2019 13:10:15

Burden of disease and health economic analysis of patients with Benign Prostatic Hyperplasia (BPH) in Brazil

GSK study ID
116340
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Burden of disease and health economic analysis of patients with Benign Prostatic Hyperplasia (BPH) in Brazil
Trial description: This is an observational medical chart review of patients with BPH that aims to investigate the epidemiological profile, diagnostic and therapeutic approach and use of healthcare resources by patients with BPH in Brazil.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Total cost of BPH treatment in Brazil

Timeframe: Last 03 years of HPB treatment

Secondary outcomes:

Epidemiologic profile

Timeframe: Last 03 years of HPB treatment

Interventions:
  • Other: Not Applicable
    • Enrollment:
    Not applicable
    Primary completion date:
    2015-30-11
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride, dutasteride/tamsulosin, tamsulosin
    Collaborators
    Not applicable
    Study date(s)
    March 2012 to November 2015
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    50+ years
    Accepts healthy volunteers
    Not applicable
    • Patients with age ≥ 50 years with diagnosis of Benign Prostatic Hyperplasia N40 (International Classification of Diseases version 10)
    • Diagnosed and followed for at least 3 years
    • Patients with diagnose of prostatic cancer
    • Patients with diagnose of bladder cancer
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients with age ≥ 50 years with diagnosis of Benign Prostatic Hyperplasia N40 (International Classification of Diseases version 10)
    • Diagnosed and followed for at least 3 years
    • Patients from Brazilian Public Health System (SUS) or private clinics
    • Patients must have medical visits scheduled within 12 weeks
    Exclusion criteria:
    • Patients with diagnose of prostatic cancer
    • Patients with diagnose of bladder cancer
    • Patients with lower urinary tract symptoms (LUTS) not associated with Benign Prostatic Hyperplasia

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Campinas, São Paulo, Brazil
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Rio de Janeiro, Rio De Janeiro, Brazil, 20 551-030
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Rio de Janeiro, Rio De Janeiro, Brazil, 20020022
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    São Paulo, São Paulo, Brazil, 05403-900
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Other
    Actual primary completion date
    2015-30-11
    Actual study completion date
    2015-30-11

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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