Last updated: 11/07/2018 05:34:56

Adherence Benefits in Tx Enlarged Prostate:Medstat

GSK study ID
113074
See study documents
Clinicaltrials.gov ID
Not applicable
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: Value of Early 5-alpha-reductase Inhibitor (5ARI) Treatment in Patients Receiving Combination 5ARI and Alpha-Blocker (AB) Therapy for Enlarged Prostate (EP)
Trial description: GHO-09-0244: Value Value of Early 5-alpha-reductase Inhibitor (5ARI) Treatment in Patients Receiving Combination 5ARI and Alpha-Blocker (AB) Therapy for Enlarged Prostate (EP) A MarketScan Database Assessment
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

To assess the proportion of patients with clinical progression (defined as acute urinary retention [AUR] or prostate-related surgery) in those receiving combination therapy (5ARI + AB) with early vs late 5ARI initiation.

Timeframe: Within the defined study period, claims will be assessed for a 7-month time period, beginning after a 5-month outcomes exclusionary peri-period from the date of the first prescription claim for an AB.

Secondary outcomes:

To assess the medical costs in patients receiving combination therapy (5ARI + AB) with early vs late 5ARI initiation.

Timeframe: Within the defined study period, medical costs will be assessed for a 7-month time period, beginning after a 5-month outcomes exclusionary peri-period from the date of the first prescription claim for an AB.

To assess the pharmacy costs in patients receiving combination therapy (5ARI + AB) with early vs late 5ARI initiation.

Timeframe: Within the defined study period, pharmacy costs will be assessed for the entire 1-year follow-up period from the date of the first prescription claim for an AB.

Interventions:
  • Drug: 5ARI + AB
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Other
    Clinical publications:
    Eric J. Kruep, Susan L. Hogue, Michael T. Eaddy, Monica D. Chandra. Clinical and Economic Impact of Early versus Delayed 5a-reductase Inhibitor Therapy in Men on Alpha Blockers for Symptomatic Benign Prostatic Hyperplasia . [P & T]. 2011;36(8):493-507.
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride
    Collaborators
    Not applicable
    Study date(s)
    March 2009 to August 2009
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Male
    Age
    50+ years
    Accepts healthy volunteers
    none
    • Male patients aged 50 years or older with a medical claim of enlarged prostate and prescription claims for both an AB and 5ARI (5ARI claim must be within 6 months of initiating an AB). Patients were required to be continuously eligible for 6 months prior to and at least 12 months after index prescription date.
    • Patients with prostate or bladder cancer; any prostate-related surgical procedure or any surgical procedure prior to the index prescription date and in the 5 month peri-period; prescription claim for finasteride indicative of male pattern baldness
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Male patients aged 50 years or older with a medical claim of enlarged prostate and prescription claims for both an AB and 5ARI (5ARI claim must be within 6 months of initiating an AB). Patients were required to be continuously eligible for 6 months prior to and at least 12 months after index prescription date.
    Exclusion criteria:
    • Patients with prostate or bladder cancer; any prostate-related surgical procedure or any surgical procedure prior to the index prescription date and in the 5 month peri-period; prescription claim for finasteride indicative of male pattern baldness

    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
    2009-20-08

    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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