Last updated: 11/07/2018 07:05:27

Dutasteride in Enlarged Prostate economic assessment: A retrospective database pooled analysis of early 5-alpha reductase inhibitor use

GSK study ID
113984
See study documents
Clinicaltrials.gov ID
NCT01332435
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Dutasteride in Enlarged Prostate economic assessment: A retrospective database pooled analysis of early 5-alpha reductase inhibitor use
Trial description: This retrospective study aims to assess the economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information Solutions and PharMetrics databases will be utilized for this study (2000-2007).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of Participants with Clinical Progression

Timeframe: Day 1 of a 1-day study

Number of Participants with Acute Urinary Retention

Timeframe: Day 1 of a 1-day study

Number of Participants Who Needed Prostate-Related Surgery

Timeframe: Day 1 of a 1-day study

Secondary outcomes:

Total BPH-related Costs

Timeframe: Day 1 of a 1-day study

BPH-related Medical Costs

Timeframe: Day 1 of a 1-day study

BPH-related Pharmacy Costs

Timeframe: Day 1 of a 1-day study

Interventions:
  • Drug: 5ARI + AB
    • Enrollment:
    6896
    Primary completion date:
    2010-19-03
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Michael Naslund, Michael T. Eaddy, Eric J. Kruep, Manan B. Shah . Economic Impact of Delaying 5a-reductase Inhibitor Therapy in Men Receiving Treatment for Symptomatic Benign Prostatic Hyperplasia . [American Health and Drug Benefits]. 2011;3(3):155-162.
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride
    Collaborators
    Not applicable
    Study date(s)
    November 2009 to March 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    50+ years
    Accepts healthy volunteers
    No
    • Male patients aged 50 years or older
    • a medical claim of EP
    • diagnosis of prostate or bladder cancer
    • any prostate-related surgical procedure within 5 months of index date
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Male patients aged 50 years or older
    • a medical claim of EP
    • a prescription claim for a 5ARI and AB (provided both are within 180 days of index date)
    • continuously eligible for 6 months prior to and at least 12 months after index prescription date.
    Exclusion criteria:
    • diagnosis of prostate or bladder cancer
    • any prostate-related surgical procedure within 5 months of index date
    • prescription claim for finasteride indicative of male pattern baldness
    • 5ARI therapy initiated prior to initiating AB therapy -

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    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
    Study complete
    Actual primary completion date
    2010-19-03
    Actual study completion date
    2010-19-03

    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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