Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01390870
• Collaborator: (none)
• Enrollment: 400
• Duration (Months): 16

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia	Drug: 5ARI or AB or Combination Therapy (5ARI + AB)

Study Design

• Study Type: Observational
• Actual Enrollment: 400 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

Patient Survey Men from the United States aged 50 years or older who initiated medication for EP within the past 12 months.

Drug: 5ARI or AB or Combination Therapy (5ARI + AB); 5ARI: Dutasteride or Finasteride; AB: Doxazosin, Silodosin, Tamsulosin, Terazosin, or Alfuzosin; Other Names: 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 Rapaflo® is a registered trademark of Watson Pharma Inc Proscar® is a registered trademark of Merck Flomax® is a registered trademark of Boehringer-Ingelheim

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reporting Compliance With Medication [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with prostate cancer

• no health/prescription insurance

• patients receiving medication(s) for EP on a PRN basis

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01390870
• Other Study ID Numbers: 112597
• First Posted: Jul 11, 2011
• Last Update Posted: May 17, 2017
• Last Verified: May 1, 2017

• Keywords provided by GlaxoSmithKline: Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, adherence
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia; Alfuzosin

Study Results

Participant Flow

Pre-assignment Detail	Participants were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a participant cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Arm/Group Title	All Enrolled Participants
Arm/Group Description	Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
Period Title: Overall Study
STARTED	400
COMPLETED	400
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Enrolled Participants
Arm/Group Description	Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
Overall Participants	400
Age, Customized (Number) [Number]
at least 50 years old	400 100%
less than 50 years old	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	400 100%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	391 97.8%
African American	2 0.5%
Hispanic	1 0.3%
Other	6 1.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reporting Compliance With Medication
Description	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.
Time Frame	Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010)

Outcome Measure Data

Analysis Population Description

All enrolled participants taking 5-alpha reductase inhibitors and/or alpha blockers

Arm/Group Title	All Enrolled Participants
Arm/Group Description	Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
Measure Participants	400
Compliant	239 59.8%
Non-Compliant	161 40.3%

Adverse Events

Adverse Event Reporting Description	This was a survey of participants, and adverse event/serious adverse event information was not captured in the study.
Arm/Group Title	All Enrolled Participants
Arm/Group Description	Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
All Cause Mortality
	All Enrolled Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Enrolled Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	All Enrolled Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.