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
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2010-19-03
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)

No location data available.

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
Finalized
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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