Prostatic HyperplasiaNCT01390870
Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence
An observational study of Prostatic Hyperplasia, run by GlaxoSmithKline.
Trial summary
Patient-based surveys will be conducted to evaluate the drivers of medication adherence in patients treated with either 5-alpha-reductase inhibitor (5ARI) therapy, alpha-blocker (AB) therapy, or combination therapy for enlarged prostate (EP). Adherence with EP therapy will be evaluated. 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 or AB or Combination Therapy (5ARI + AB)
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Sep 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: Inclusion criteria: * Physician confirmed diagnosis of enlarged prostate (EP) * Age 50 or older * Resident of the United States with health insurance that covers prescription drugs * EP is consistently treated with a medication that was intiated within the previous 12 months Exclusion criteria * age less than 50 * receiving medication on an as needed basis * diagnosis of prostate cancer
Who may be able to join
- Males
- Aged 50 years or older
- Residents of the United States
- Receiving a prescription for an enlarged prostate (EP) treatment within 12 months prior to survey initiation
Who cannot join
- Patients with prostate cancer
- no health/prescription insurance
- patients receiving medication(s) for EP on a PRN basis
About this study
Patient-based surveys will be conducted to evaluate the drivers of medication adherence in patients treated with either 5-alpha-reductase inhibitor (5ARI) therapy, alpha-blocker (AB) therapy, or combination therapy for enlarged prostate (EP). Adherence with EP therapy will be evaluated. The researchers believe that the majority of participants will report that they are compliant with therapy. The data source is a cross-sectional patient survey administered at one time point.
- Conditions
- Prostatic Hyperplasia
- Being tested
- 5ARI or AB or Combination Therapy (5ARI + AB)
- Keywords
- Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, adherence
- 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 or AB or Combination Therapy (5ARI + AB)Drug
Also called Hytrin® is a registered trademark of Abbott Labs, Uroxatral® is a registered trademark of Sanofi-Aventis, Avodart® is a registered trademark of GlaxoSmithKline, Cardura® is a registered trademark of Pfizer
5ARI: Dutasteride or Finasteride; AB: Doxazosin, Silodosin, Tamsulosin, Terazosin, or Alfuzosin
| Study group | Role | What they receive |
|---|---|---|
| Patient Survey | Men from the United States aged 50 years or older who initiated medication for EP within the past 12 months. Receives: Drug: 5ARI or AB or Combination Therapy (5ARI + AB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Compliance With Medication
Compliance was calculated based on the participant's response to the following question: "In general, how many times did you miss taking your prostate medication?" Responses were measured on a 5-point scale. Participants who answered "I never miss a dose of my medication" were considered compliant. All other responses were considered non-compliant.
Measured: Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startMay 2009
- Primary completionSep 2010
- Study completionSep 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 400 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
- NCT01390870
- Sponsor's protocol ID
- 112597
- Status last verified
- May 2017
- First submitted
- 14 Apr 2011
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence
- ClinicalTrials.gov ID
- NCT01390870
- Acronym / sponsor ID
- 112597
- Conditions
- Prostatic Hyperplasia
- Keywords
- Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Posted 21 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient-based surveys will be conducted to evaluate the drivers of medication adherence in patients treated with either 5-alpha-reductase inhibitor (5ARI) therapy, alpha-blocker (AB) therapy, or combination therapy for enlarged prostate (EP). Adherence with EP therapy will be evaluated. The researchers believe that the majority of participants will report that they are compliant with therapy. The data source is a cross-sectional patient survey administered at one time point.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Survey | – | Drug: 5ARI or AB or Combination Therapy (5ARI + AB)Men from the United States aged 50 years or older who initiated medication for EP within the past 12 months. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion criteria: * Physician confirmed diagnosis of enlarged prostate (EP) * Age 50 or older * Resident of the United States with health insurance that covers prescription drugs * EP is consistently treated with a medication that was intiated within the previous 12 months Exclusion criteria * age less than 50 * receiving medication on an as needed basis * diagnosis of prostate cancer
Key inclusion criteria (4 listed)
- Males
- Aged 50 years or older
- Residents of the United States
- Receiving a prescription for an enlarged prostate (EP) treatment within 12 months prior to survey initiation
Key exclusion criteria (3 listed)
- Patients with prostate cancer
- no health/prescription insurance
- patients receiving medication(s) for EP on a PRN basis
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 or AB or Combination Therapy (5ARI + AB)Also: Hytrin® is a registered trademark of Abbott Labs, Uroxatral® is a registered trademark of Sanofi-Aventis, Avodart® is a registered trademark of GlaxoSmithKline, Cardura® is a registered trademark of Pfizer5ARI: Dutasteride or Finasteride; AB: Doxazosin, Silodosin, Tamsulosin, Terazosin, or Alfuzosin | Drug | Patient Survey |
Primary outcome
Number of Participants Reporting Compliance With Medication
Time frame: Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010)
Compliance was calculated based on the participant's response to the following question: "In general, how many times did you miss taking your prostate medication?" Responses were measured on a 5-point scale. Participants who answered "I never miss a dose of my medication" were considered compliant. All other responses were considered non-compliant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 4 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 17 May 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 21 Mar 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 Reporting Compliance With Medication (time frame: Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010)). 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 17 May 2017.