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Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use

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ClinicalTrials.gov Identifier: NCT01332435
Recruitment Status : Completed
First Posted : April 11, 2011
Results First Posted : July 22, 2011
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date April 7, 2011
First Posted Date April 11, 2011
Results First Submitted Date April 14, 2011
Results First Posted Date July 22, 2011
Last Update Posted Date June 27, 2017
Study Start Date November 2009
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 23, 2011)
  • Number of Participants With Clinical Progression [ Time Frame: Day 1 of a 1-day study ]
    Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes.
  • Number of Participants With Acute Urinary Retention [ Time Frame: Day 1 of a 1-day study ]
    Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.
  • Number of Participants Who Needed Prostate-Related Surgery [ Time Frame: Day 1 of a 1-day study ]
    Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.
Original Primary Outcome Measures
 (submitted: April 7, 2011)
To assess total healthcare costs associated with EP [ Time Frame: Medical costs will be assessed for a 7-month time period, beginning after a 5-month outcomes exclusionary peri-period. Pharmacy costs will be assessed for the entire 1 year follow-up period. ]
Change History Complete list of historical versions of study NCT01332435 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 4, 2011)
  • Total BPH-related Costs [ Time Frame: Day 1 of a 1-day study ]
    All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
  • BPH-related Medical Costs [ Time Frame: Day 1 of a 1-day study ]
    Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
  • BPH-related Pharmacy Costs [ Time Frame: Day 1 of a 1-day study ]
    Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use
Official Title Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use
Brief Summary 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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population This study aims to identify eligible patient data between July 1, 2000, and December 31, 2006, and allows for patient data to be followed for 6 months prior to and up to 1 year following index prescription date.
Condition Prostatic Hyperplasia
Intervention Drug: 5ARI + AB
5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin
Study Groups/Cohorts
  • Early 5ARI Initiation
    Patients with EP receiving combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB)
    Intervention: Drug: 5ARI + AB
  • Late 5ARI Initiation
    Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (more than 30 days but less than 6 months after initiation of AB)
    Intervention: Drug: 5ARI + AB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 23, 2011)
6896
Original Enrollment Not Provided
Actual Study Completion Date January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01332435
Other Study ID Numbers 113984
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2017