Prostatic HyperplasiaNCT01381510
Establishing the Benefits of Adherence to Enlarged Prostate Treatment: A Validation Study Linking Adherence to Outcomes Using the Market Scan Database
An observational study of Prostatic Hyperplasia, run by GlaxoSmithKline.
Trial summary
Adherence and length of therapy with 5-alpha reductase inhibitor (5ARI) treatment may be associated with improved clinical outcomes of enlarged prostate (EP) as well as lower health care costs. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- 5-alpha Reductase Inhibitor (5ARI)
- How many people
- 54,459 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study is populated with claims data from male health plan members and Medicare patients age 50 and older who were continuously enrolled in a health plan that feeds into the MarketScan database between July 1, 2003 and May 1, 2009. Patient records were analyzed for 6 months prior to and at least 150 days following the index date for the first 5-alpha reductase inhibitor (5ARI) treatment
Who may be able to join
- Male
- Aged 50 years or older
- A diagnostic claim of benign prostatic hyperplasia (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes 222.2x or 600.xx)
- A prescription claim for a 5-alpha reductase inhibitor (5ARI) for at least 60 days during the observation period
- Continuous health plan eligibilitiy for 6 months prior to and at least 150 days after the initial 5ARI prescription
Who cannot join
- A diagnosis of prostate cancer (ICD-9-CM codes 185.xx, 198.82, 233.4, 236.5, 239.5, V10.46)
- A diagnosis of bladder cancer (ICD-9-CM codes 188.xx, 198.1, 223.3, 233.7, 239.4, V10.51),
- A procedure code for any prostate-related surgery prior to the index date or 150 days after the index date
- A diagnosis code for acute urinary retention (AUR) prior to the index date or 150 days after the index date
About this study
Adherence and length of therapy with 5-alpha reductase inhibitor (5ARI) treatment may be associated with improved clinical outcomes of enlarged prostate (EP) as well as lower health care costs.
The objective of this retrospective database analysis is to quantify the relationship between adherence and length of therapy with a 5ARI and the likelihood of acute urinary retention (AUR) or prostate surgery (emergency and non-emergency) in patients with benign prostatic hyperplasia (BPH). The study will also measure the economic impact associated with these medical encounters.
Read more
The MarketScan database contains data from people with commercial health insurance and Medicare and includes both medical and pharmacy data that are sourced directly from health plans and employers. Approximately 18 million covered lives will be utilized for this study in the time period from January 1, 2003 to September 30, 2009.
This study is a retrospective cohort analysis of medical claims data.
- Conditions
- Prostatic Hyperplasia
- Being tested
- 5-alpha Reductase Inhibitor (5ARI)
- Keywords
- Benign prostatic hyperplasia, Adherence, Acute urinary retention, Enlarged prostate, 5-alpha reductase inhibitor, Surgery, Cost and cost analysis
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-alpha Reductase Inhibitor (5ARI)Drug
Also called Proscar ® (finasteride), Avodart ® (dutasteride)
A 5ARI: Either dutasteride or finisteride
| Study group | Role | What they receive |
|---|---|---|
| Adherent BPH patients | Patients with benign prostatic hyperplasia (BPH) who are adherent to 5-alpha reductase inhibitor (5ARI) therapy based on a medication possession ratio (MPR). Analyses will be conducted with threshold adherence levels of 70%, 75% and 80% Receives: Drug: 5-alpha Reductase Inhibitor (5ARI) | |
| Non-adherent BPH patients | Patients with BPH who are not adherent to 5ARI therapy based on an MPR and threshold levels of less than 70%, less than 75% and less than 80% Receives: Drug: 5-alpha Reductase Inhibitor (5ARI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurence of a diagnosis code for acute urinary retention (AUR) or a procedure code for prostate surgery
The occurence of a code for either AUR or prostate surgery will be identified for patients who were adherent with 5ARI therapy as measured with a medication possession ratio (MPR)
Measured: One year following the first date of 5ARI therapy
Secondary outcomes (1)
Mean costs associated with AUR or prostate surgery
The mean costs of outpatient and inpatient visits associated with the diagnosis code for AUR or the procedure codes for prostate surgery will be compared between patients who were compliant with 5ARI therapy and those who were not
Measured: One year following the first date of 5ARI therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJun 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 54,459 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381510
- Sponsor's protocol ID
- 113909
- Status last verified
- Aug 2012
- First submitted
- 23 Jun 2011
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Benefits of Adherence to Enlarged Prostate Treatment: A Validation Study Linking Adherence to Outcomes Using the Market Scan Database
- ClinicalTrials.gov ID
- NCT01381510
- Acronym / sponsor ID
- 113909
- Conditions
- Prostatic Hyperplasia
- Keywords
- Benign prostatic hyperplasia, Adherence, Acute urinary retention, Enlarged prostate, 5-alpha reductase inhibitor, Surgery, Cost and cost analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54,459 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adherence and length of therapy with 5-alpha reductase inhibitor (5ARI) treatment may be associated with improved clinical outcomes of enlarged prostate (EP) as well as lower health care costs.
The objective of this retrospective database analysis is to quantify the relationship between adherence and length of therapy with a 5ARI and the likelihood of acute urinary retention (AUR) or prostate surgery (emergency and non-emergency) in patients with benign prostatic hyperplasia (BPH). The study will also measure the economic impact associated with these medical encounters.
The MarketScan database contains data from people with commercial health insurance and Medicare and includes both medical and pharmacy data that are sourced directly from health plans and employers. Approximately 18 million covered lives will be utilized for this study in the time period from January 1, 2003 to September 30, 2009.
This study is a retrospective cohort analysis of medical claims data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adherent BPH patients | – | Drug: 5-alpha Reductase Inhibitor (5ARI)Patients with benign prostatic hyperplasia (BPH) who are adherent to 5-alpha reductase inhibitor (5ARI) therapy based on a medication possession ratio (MPR). Analyses will be conducted with threshold adherence levels of 70%, 75% and 80% |
| Non-adherent BPH patients | – | Drug: 5-alpha Reductase Inhibitor (5ARI)Patients with BPH who are not adherent to 5ARI therapy based on an MPR and threshold levels of less than 70%, less than 75% and less than 80% |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is populated with claims data from male health plan members and Medicare patients age 50 and older who were continuously enrolled in a health plan that feeds into the MarketScan database between July 1, 2003 and May 1, 2009. Patient records were analyzed for 6 months prior to and at least 150 days following the index date for the first 5-alpha reductase inhibitor (5ARI) treatment
Key inclusion criteria (5 listed)
- Male
- Aged 50 years or older
- A diagnostic claim of benign prostatic hyperplasia (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes 222.2x or 600.xx)
- A prescription claim for a 5-alpha reductase inhibitor (5ARI) for at least 60 days during the observation period
- Continuous health plan eligibilitiy for 6 months prior to and at least 150 days after the initial 5ARI prescription
Key exclusion criteria (4 listed)
- A diagnosis of prostate cancer (ICD-9-CM codes 185.xx, 198.82, 233.4, 236.5, 239.5, V10.46)
- A diagnosis of bladder cancer (ICD-9-CM codes 188.xx, 198.1, 223.3, 233.7, 239.4, V10.51),
- A procedure code for any prostate-related surgery prior to the index date or 150 days after the index date
- A diagnosis code for acute urinary retention (AUR) prior to the index date or 150 days after the index date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-alpha Reductase Inhibitor (5ARI)Also: Proscar ® (finasteride), Avodart ® (dutasteride)A 5ARI: Either dutasteride or finisteride | Drug | Adherent BPH patients, Non-adherent BPH patients |
Primary outcome
The occurence of a diagnosis code for acute urinary retention (AUR) or a procedure code for prostate surgery
Time frame: One year following the first date of 5ARI therapy
The occurence of a code for either AUR or prostate surgery will be identified for patients who were adherent with 5ARI therapy as measured with a medication possession ratio (MPR)
1 secondary outcome
Mean costs associated with AUR or prostate surgery
Time frame: One year following the first date of 5ARI therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Hyperplasia, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurence of a diagnosis code for acute urinary retention (AUR) or a procedure code for prostate surgery (time frame: One year following the first date of 5ARI therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2012.