Prostatic HyperplasiaNCT01323998

Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

An observational study of Prostatic Hyperplasia, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This retrospective study aims to assess treatment patterns within 1 year of initiating BPH treatment, including 5-alpha-reductase inhibitor (5ARI) monotherapy, alpha-blocker (AB) monotherapy, early combination therapy, and delayed combination therapy. The MarketScan database will be utilized for this study (2000-2008) 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?: 5ARI and AB
How many people: 35,032 participants
Where: No sites listed yet
Study dates: Apr 2010to Jun 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Male patients aged 50 years or older with a diagnostic claim for BPH and at least one prescription claim for a 5ARI or AB in the enrollment period

Who may be able to join

Male
aged 50 years or older
a diagnostic claim for BPH
at least one prescription claim for a 5ARI or AB in the enrollment period
continuous eligibility for 6 months prior to and 12 months after index prescription date

Who cannot join

diagnosis of prostate or bladder cancer during the study period
any prostate-related surgical procedure within 1 month of the index prescription date
prescription claim for finasteride 1 mg for male pattern baldness during the study period

About this study

Official title: Evaluating the Treatment Patterns in Men With Benign Prostatic Hypertrophy (Marketscan Database Study)

Conditions: Prostatic Hyperplasia
Being tested: 5ARI, AB
Keywords: enlarged prostate, Benign prostatic hyperplasia, alpha-blocker, 5-alpha-reductase inhibitor
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

5ARIDrug
Dutasteride or Finasteride
ABDrug
Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin

Study groups in NCT01323998
Study group	Role	What they receive
5ARI monotherapy		Patients with BPH receiving 5ARI monotherapy Receives: Drug: 5ARI
AB monotherapy		Patients with BPH receiving AB monotherapy Receives: Drug: AB
Early combination (5ARI + AB) therapy		Patients receiving early initiation of combination therapy with a 5ARI plus AB. Early initiation defined as starting 5ARI therapy within 30 days of initiating AB therapy Receives: Drug: 5ARI; Drug: AB
Delayed combination (5ARI + AB) therapy		Patients receiving delayed initiation of combination therapy with a 5ARI plus AB. Delayed initiation defined as starting 5ARI therapy more than 30 days but less than 6 months after initiating AB therapy Receives: Drug: 5ARI; Drug: AB

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis
The number of participants treated with alpha-blocker (AB) and 5a lpha reductase inhibitor (5ARI) as monotherapy or in combination reported by the presence or absence of a diagnosis code for BPH (International Classification of Disease, Ninth Revision, Clinical Modification codes: 222.2 and 600.xx). Early combination therapy was defined as the addition of 5ARI to existing AB therapy within 30 days of the initial AB pharmacy claim. Delayed combination therapy was defined as the addition of 5ARI to AB therapy after 30 day but within one year of the initial AB pharmacy claim.
Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Jun 2010

First posted28 Mar 2011 (estimated)
Study startApr 2010
Primary completionJun 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 35,032 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01323998
Sponsor's protocol ID: 114462
Status last verified: Jun 2017
First submitted: 24 Mar 2011
Last updated: 6 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 1/2
RT-310 Safety and Feasibility BPH Study
BPH (Benign Prostatic Hyperplasia)
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
Not yet recruiting
Prostatic Artery Embolization Using Histoacryl as a Novel Embolizing Agent for Treatment of BPH
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Recruiting
Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
BPH (Benign Prostatic Hyperplasia)
Recruiting
Comparing Rezum and Urolift
Benign Prostatic Hyperplasia

All Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Treatment Patterns in Men With Benign Prostatic Hypertrophy (Marketscan Database Study)
ClinicalTrials.gov ID: NCT01323998
Acronym / sponsor ID: 114462
Conditions: Prostatic Hyperplasia
Keywords: enlarged prostate, Benign prostatic hyperplasia, alpha-blocker, 5-alpha-reductase inhibitor
Study type: Observational
Recruitment status: Completed
Enrolment: 35,032 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 28 Mar 2011 (estimated)
Results: Posted 29 Feb 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 4

Arm	Type	Receives
5ARI monotherapy	–	Drug: 5ARIPatients with BPH receiving 5ARI monotherapy
AB monotherapy	–	Drug: ABPatients with BPH receiving AB monotherapy
Early combination (5ARI + AB) therapy	–	Drug: 5ARI, Drug: ABPatients receiving early initiation of combination therapy with a 5ARI plus AB. Early initiation defined as starting 5ARI therapy within 30 days of initiating AB therapy
Delayed combination (5ARI + AB) therapy	–	Drug: 5ARI, Drug: ABPatients receiving delayed initiation of combination therapy with a 5ARI plus AB. Delayed initiation defined as starting 5ARI therapy more than 30 days but less than 6 months after initiating AB therapy

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Male patients aged 50 years or older with a diagnostic claim for BPH and at least one prescription claim for a 5ARI or AB in the enrollment period

Key inclusion criteria (5 listed)

Male
aged 50 years or older
a diagnostic claim for BPH
at least one prescription claim for a 5ARI or AB in the enrollment period
continuous eligibility for 6 months prior to and 12 months after index prescription date

Key exclusion criteria (3 listed)

diagnosis of prostate or bladder cancer during the study period
any prostate-related surgical procedure within 1 month of the index prescription date
prescription claim for finasteride 1 mg for male pattern baldness during the study period

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
5ARIDutasteride or Finasteride	Drug	5ARI monotherapy, Delayed combination (5ARI + AB) therapy, Early combination (5ARI + AB) therapy
ABDoxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin	Drug	AB monotherapy, Delayed combination (5ARI + AB) therapy, Early combination (5ARI + AB) therapy

Primary outcome

Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis
Time frame: 4 years
The number of participants treated with alpha-blocker (AB) and 5a lpha reductase inhibitor (5ARI) as monotherapy or in combination reported by the presence or absence of a diagnosis code for BPH (International Classification of Disease, Ninth Revision, Clinical Modification codes: 222.2 and 600.xx). Early combination therapy was defined as the addition of 5ARI to existing AB therapy within 30 days of the initial AB pharmacy claim. Delayed combination therapy was defined as the addition of 5ARI to AB therapy after 30 day but within one year of the initial AB pharmacy claim.

Results and safety

Results posted to the registry on 29 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alpha-blocker (AB) Monotherapy	200,631	200,631
5 Alpha Reductase Inhibitor (5ARI) Monotherapy	18,681	18,681
AB Plus 5ARI Combination Therapy, Early 5ARI Starters	10,294	10,294
AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters	12,052	12,052
5ARI Plus AB Combination Therapy	6,735	6,735

Primary outcome: Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis

Time frame: 4 years. Number. Unit: participants

Measure	Alpha-blocker (AB) Monotherapy n = 200631	5 Alpha Reductase Inhibitor (5ARI) Monotherapy n = 18681	AB Plus 5ARI Combination Therapy, Early 5ARI Starters n = 10294	AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters n = 12052	5ARI Plus AB Combination Therapy n = 6735
Participants without a diagnosis code for BPH	122307	9456	3293	3674	2625
Participants with a diagnosis code for BPH	78324	9225	7001	8378	4110

Population analysed: Males aged 50 and older with a new pharmacy claim for AB, 5ARI or a combination of both. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 milligram, or a procedure code for prostate surgery.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alpha-blocker (AB) Monotherapy	0 of 0	0 of 0	Not reported
5 Alpha Reductase Inhibitor (5ARI) Monotherapy	0 of 0	0 of 0	Not reported
AB Plus 5ARI Combination Therapy, Early 5ARI Starters	0 of 0	0 of 0	Not reported
AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters	0 of 0	0 of 0	Not reported
5ARI Plus AB Combination Therapy	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prostatic Hyperplasia

Active, not recruitingPhase 1/2
RT-310 Safety and Feasibility BPH Study
BPH (Benign Prostatic Hyperplasia)
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
Not yet recruiting
Prostatic Artery Embolization Using Histoacryl as a Novel Embolizing Agent for Treatment of BPH
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Recruiting
Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
BPH (Benign Prostatic Hyperplasia)
Recruiting
Comparing Rezum and Urolift
Benign Prostatic Hyperplasia

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 3 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 6 Jul 2017. 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?

Yes. Results are posted in the registry (first posted 29 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01323998.

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 6 Jul 2017.