Last updated: 11/03/2018 15:49:33

Establishing the Benefits of Adherence to Enlarged Prostate Treatment: A Validation Study Linking Adherence to Outcomes Using the Market Scan Database

GSK study ID
113909
See study documents
Clinicaltrials.gov ID
NCT01381510
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: Establishing the Benefits of Adherence to Enlarged Prostate Treatment: A Validation Study Linking Adherence to Outcomes Using the Market Scan Database
Trial description: Adherence and length of therapy with 5-alpha reductase inhibitor (5ARI) treatment may be associated with improved clinical outcomes of enlarged prostate (EP) as well as lower health care costs.
The objective of this retrospective database analysis is to quantify the relationship between adherence and length of therapy with a 5ARI and the likelihood of acute urinary retention (AUR) or prostate surgery (emergency and non-emergency) in patients with benign prostatic hyperplasia (BPH). The study will also measure the economic impact associated with these medical encounters.
The MarketScan database contains data from people with commercial health insurance and Medicare and includes both medical and pharmacy data that are sourced directly from health plans and employers. Approximately 18 million covered lives will be utilized for this study in the time period from January 1, 2003 to September 30, 2009.
This study is a retrospective cohort analysis of medical claims data.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The occurence of a diagnosis code for acute urinary retention (AUR) or a procedure code for prostate surgery

Timeframe: One year following the first date of 5ARI therapy

Secondary outcomes:

Mean costs associated with AUR or prostate surgery

Timeframe: One year following the first date of 5ARI therapy

Interventions:
  • Drug: 5-alpha Reductase Inhibitor (5ARI)
    • Enrollment:
    54459
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride
    Collaborators
    Not applicable
    Study date(s)
    June 2010 to August 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    50+ years
    Accepts healthy volunteers
    No
    • Male
    • Aged 50 years or older
    • A diagnosis of prostate cancer (ICD-9-CM codes 185.xx, 198.82, 233.4, 236.5, 239.5, V10.46)
    • A diagnosis of bladder cancer (ICD-9-CM codes 188.xx, 198.1, 223.3, 233.7, 239.4, V10.51),
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Male
    • Aged 50 years or older
    • A diagnostic claim of benign prostatic hyperplasia (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes 222.2x or 600.xx)
    • A prescription claim for a 5-alpha reductase inhibitor (5ARI) for at least 60 days during the observation period
    • Continuous health plan eligibilitiy for 6 months prior to and at least 150 days after the initial 5ARI prescription
    Exclusion criteria:
    • A diagnosis of prostate cancer (ICD-9-CM codes 185.xx, 198.82, 233.4, 236.5, 239.5, V10.46)
    • A diagnosis of bladder cancer (ICD-9-CM codes 188.xx, 198.1, 223.3, 233.7, 239.4, V10.51),
    • A procedure code for any prostate-related surgery prior to the index date or 150 days after the index date
    • A diagnosis code for acute urinary retention (AUR) prior to the index date or 150 days after the index date

    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
    Not applicable
    Actual study completion date
    2010-25-08

    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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