Prostatic HyperplasiaNCT01332435

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

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 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. 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 + AB
How many people: 6,896 participants
Where: No sites listed yet
Study dates: Nov 2009to Jan 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: 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.

Who may be able to join

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.

Who cannot join

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

About this study

Conditions: Prostatic Hyperplasia
Being tested: 5ARI + AB
Keywords: Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, early, costs
Medical subject headings: Prostatic Hyperplasia

What participants receive

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

5ARI + ABDrug
5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin

Study groups in NCT01332435
Study group	Role	What they receive
Early 5ARI Initiation		Patients with EP receiving combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB) Receives: 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) Receives: Drug: 5ARI + AB

What is being measured

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

Number of Participants With Clinical Progression
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.
Measured: Day 1 of a 1-day study
Number of Participants With Acute Urinary Retention
Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.
Measured: Day 1 of a 1-day study
Number of Participants Who Needed Prostate-Related Surgery
Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.
Measured: Day 1 of a 1-day study

Secondary outcomes (3)

Total BPH-related Costs
All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
Measured: Day 1 of a 1-day study
BPH-related Medical Costs
Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
Measured: Day 1 of a 1-day study
BPH-related Pharmacy Costs
Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
Measured: Day 1 of a 1-day study

Timeline

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

Nov 2009Jan 2010

First posted11 Apr 2011 (estimated)
Study startNov 2009
Primary completionJan 2010
Study completionJan 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: 6,896 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01332435
Sponsor's protocol ID: 113984
Status last verified: Jun 2017
First submitted: 7 Apr 2011
Last updated: 27 Jun 2017
Results posted: Yes, on ClinicalTrials.gov

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 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use
ClinicalTrials.gov ID: NCT01332435
Acronym / sponsor ID: 113984
Conditions: Prostatic Hyperplasia
Keywords: Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, early, costs
Study type: Observational
Recruitment status: Completed
Enrolment: 6,896 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 11 Apr 2011 (estimated)
Results: Posted 22 Jul 2011

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: 2

Arm	Type	Receives
Early 5ARI Initiation	–	Drug: 5ARI + ABPatients with EP receiving combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB)
Late 5ARI Initiation	–	Drug: 5ARI + ABPatients 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)

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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

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
5ARI + AB5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin	Drug	Early 5ARI Initiation, Late 5ARI Initiation

Primary outcome

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.

3 secondary outcomes

Total BPH-related Costs
Time frame: Day 1 of a 1-day study
BPH-related Medical Costs
Time frame: Day 1 of a 1-day study
BPH-related Pharmacy Costs
Time frame: Day 1 of a 1-day study

Results and safety

Results posted to the registry on 22 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IHCIS; Early 5ARI Initiation	1,572	1,572
IHCIS; Late 5ARI Initiation	1,064	1,064
PharMetrics; Early 5ARI Initiation	2,604	2,604
PharMetrics; Late 5ARI Initiation	1,656	1,656

Primary outcome: Number of Participants With Clinical Progression

Time frame: Day 1 of a 1-day study. Number. Unit: participants

Measure	IHCIS; Early 5ARI Initiation n = 1572	IHCIS; Late 5ARI Initiation n = 1064	PharMetrics; Early 5ARI Initiation n = 2604	PharMetrics; Late 5ARI Initiation n = 1656
Value	176	202	266	232

IHCIS; Early 5ARI Initiation vs IHCIS; Late 5ARI Initiation: p <0.001, Chi-squared
PharMetrics; Early 5ARI Initiation vs PharMetrics; Late 5ARI Initiation: p = 0.0002, Chi-squared

Population analysed: Enrolled Population: Men aged \>=50 years old between 7/1/2000 and 12/31/2006 with a diagnosis of benign prostatic hyperplasia and who were treated with an AB and concomitant 5-ARI therapy within 6 months of starting AB therapy

Primary outcome: Number of Participants With Acute Urinary Retention

Time frame: Day 1 of a 1-day study. Number. Unit: participants

Measure	IHCIS; Early 5ARI Initiation n = 1572	IHCIS; Late 5ARI Initiation n = 1064	PharMetrics; Early 5ARI Initiation n = 2604	PharMetrics; Late 5ARI Initiation n = 1656
Value	127	140	182	166

IHCIS; Early 5ARI Initiation vs IHCIS; Late 5ARI Initiation: p <0.001, Chi-squared
PharMetrics; Early 5ARI Initiation vs PharMetrics; Late 5ARI Initiation: p = 0.0006, Chi-squared

Population analysed: Enrolled Population

Primary outcome: Number of Participants Who Needed Prostate-Related Surgery

Time frame: Day 1 of a 1-day study. Number. Unit: participants

Measure	IHCIS; Early 5ARI Initiation n = 1572	IHCIS; Late 5ARI Initiation n = 1064	PharMetrics; Early 5ARI Initiation n = 2604	PharMetrics; Late 5ARI Initiation n = 1656
Value	75	101	130	104

IHCIS; Early 5ARI Initiation vs IHCIS; Late 5ARI Initiation: p <0.001, Chi-squared
PharMetrics; Early 5ARI Initiation vs PharMetrics; Late 5ARI Initiation: p = 0.0699, Chi-squared

Population analysed: Enrolled Population

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IHCIS; Early 5ARI Initiation	0 of 0	0 of 0	Not reported
IHCIS; Late 5ARI Initiation	0 of 0	0 of 0	Not reported
PharMetrics; Early 5ARI Initiation	0 of 0	0 of 0	Not reported
PharMetrics; Late 5ARI Initiation	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 27 Jun 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 4 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 Jun 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 22 Jul 2011). 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 With Clinical Progression (time frame: Day 1 of a 1-day study). The study lists 3 primary outcomes in all. 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 NCT01332435.

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 Jun 2017.