Last updated: 11/07/2018 07:47:37

Demonstrating the clinical and economic benefit of 5 Alpha Reductase Inhibitor adherence in Benign Prostatic Hyperplasia

GSK study ID
114482
See study documents
Clinicaltrials.gov ID
NCT01334723
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: Demonstrating the clinical and economic benefit of 5 Alpha Reductase Inhibitor adherence in Benign Prostatic Hyperplasia
Trial description: This retrospective study aims to quantify the relationship between 5-alpha-reductase inhibitor (5ARI) adherence / length of therapy and the likelihood of acute urinary retention (AUR) or prostate surgery in patients with benign prostatic hyperplasia (BPH) as well as the economic impact associated with these medical encounters. The Integrated Health Care Information Solutions (IHCIS) database will be utilized for this study (2000-2006).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of Participants with Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70%

Timeframe: The 5 and a half year period from January 1, 2000 to June 30, 2006

Number of Participants with Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75%

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Number of Participants with Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80%

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Secondary outcomes:

Mean Length of 5-ARI Therapy

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Mean BPH-Related Costs for participants with an MPR >=70% versus <70%

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Mean BPH-Related Costs for participants with an MPR >=75% versus <75%

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Mean BPH-Related Costs for participants with an MPR >=80% versus <80%

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

BPH-Related Costs for Every 30 Days of 5-ARI Therapy

Timeframe: Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006

Interventions:
Drug: Adherent with 5-alpha-reductase inhibitor (5ARI) therapy
Drug: Non-adherent to 5ARI therapy
Enrollment:
35032
Observational study model:
Cohort
Primary completion date:
2010-28-04
Time perspective:
Retrospective
Clinical publications:
Gruschkus S, Poston S, Eaddy M, Chaudhari S. Copy of 114482 PM US2526 Adherence to 5ARI Therapy in the Treatment of Benign Prostatic Hyperplasia: Does Adherence Matter From a Clinical and Economic Perspective?. [P & T Pharm and Ther]. 2012;37(8):464-477.
Medical condition
Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
April 2010 to April 2010
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Male
Age
50+ years
Accepts healthy volunteers
No
  • Male
  • aged 50 years or older
  • prostate cancer
  • any prostate-related surgical procedure prior to index date
Inclusion and exclusion criteria
Inclusion criteria:
  • Male
  • aged 50 years or older
  • a diagnostic claim of BPH
  • prescription claim for a 5ARI for at least 60 days during the observation period.
  • continuously eligible for 6 months prior to and at least 6 months after index date.
Exclusion criteria:
  • prostate cancer
  • any prostate-related surgical procedure prior to index date -

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
2010-28-04
Actual study completion date
2010-28-04

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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