Trial Outcomes & Findings for Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence (NCT NCT01390870)
NCT ID: NCT01390870
Last Updated: 2017-05-17
Results Overview
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.
COMPLETED
400 participants
Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010)
2017-05-17
Participant Flow
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.
Participant milestones
| Measure |
All Enrolled Participants
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 Study
STARTED
|
400
|
|
Overall Study
COMPLETED
|
400
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence
Baseline characteristics by cohort
| Measure |
All Enrolled Participants
n=400 Participants
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)
|
|---|---|
|
Age, Customized
at least 50 years old
|
400 Participants
n=5 Participants
|
|
Age, Customized
less than 50 years old
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
400 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
391 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010)Population: All enrolled participants taking 5-alpha reductase inhibitors and/or alpha blockers
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.
Outcome measures
| Measure |
All Enrolled Participants
n=400 Participants
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)
|
|---|---|
|
Number of Participants Reporting Compliance With Medication
Compliant
|
239 participants
|
|
Number of Participants Reporting Compliance With Medication
Non-Compliant
|
161 participants
|
Adverse Events
All Enrolled Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER