Last updated: 11/03/2018 13:06:51

Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence

GSK study ID
112597
See study documents
Clinicaltrials.gov ID
NCT01390870
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: Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence
Trial description: Patient-based surveys will be conducted to evaluate the drivers of medication adherence in patients treated with either 5-alpha-reductase inhibitor (5ARI) therapy, alpha-blocker (AB) therapy, or combination therapy for enlarged prostate (EP). Adherence with EP therapy will be evaluated. The researchers believe that the majority of participants will report that they are compliant with therapy. The data source is a cross-sectional patient survey administered at one time point.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants reporting compliance with medication

Timeframe: Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010)

Secondary outcomes:
Not applicable
Interventions:
  • Drug: 5ARI or AB or Combination Therapy (5ARI + AB)
    • Enrollment:
    400
    Primary completion date:
    2010-30-03
    Observational study model:
    Other
    Time perspective:
    Cross-Sectional
    Clinical publications:
    Not applicable
    Medical condition
    Prostatic Hyperplasia
    Product
    dutasteride
    Collaborators
    Not applicable
    Study date(s)
    May 2009 to March 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    50+ years
    Accepts healthy volunteers
    No
    • Males
    • Aged 50 years or older
    • Patients with prostate cancer
    • no health/prescription insurance
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Males
    • Aged 50 years or older
    • Residents of the United States
    • Receiving a prescription for an enlarged prostate (EP) treatment within 12 months prior to survey initiation
    Exclusion criteria:
    • Patients with prostate cancer
    • no health/prescription insurance
    • patients receiving medication(s) for EP on a PRN basis

    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
    2010-30-03
    Actual study completion date
    2010-30-03

    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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