Lower Urinary Tract Symptoms
Conditions
Brief summary
Multicenter trial conducted in Pharmacy retail centers
Interventions
DRUGtamsulosin
0.4 mg
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Men 18 years of age and older. 2. Able to speak, read and understand English. 3. Willing to participate in the study and voluntarily sign an informed consent document.
Exclusion criteria
1\. Subject or anyone in their household is currently employed by a marketing or marketing research company, and advertising agency or public relations firm, a pharmacy or pharmaceutical company, a manufacturer of medicines, a managed care or health insurance company as a healthcare professional or healthcare practice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Appropriately Followed the Label Instructions | 8 weeks | Includes subjects who reported: 1. No improvement in urinary symptoms and stopped taking product, 2. Reported worsening of urinary symptoms and stopped taking the product, 3. Reported a new urinary symptom and stopped taking the product, 4. Reported no Stop Use condition and never took more than 1 capsule on any given day, 5. Reported a Stop Use condition and contacted a provider. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Took no More Than One Capsule Per Day | 8 weeks | Percentage of participants who took no more than one capsule per day |
| Percentage of Use-Days for All Participants Who Took no More Than One Capsule Per Day | 8 weeks | Use-day was defind as a calendar day for which data were available regarding use or non-use. |
| Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase | 8 weeks | Includes participants who: 1. were less than 45 years of age at enrollment, and 2. spoke to a doctor during the actual use phase. |
| Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population | 8 weeks | Percentage of participants who are potentially at risk of harm by incorrectly selecting to use the study product out of the total study population |
| Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population | 8 weeks | Percentage of participants who have a correct self-selection response as defined by the Uses, Allergy alert, and Do Not Use sections of the Drug Facts Label. |
Countries
United States
Participant flow
Recruitment details
Study had 2 parts: In part 1 participants reviewed the product label and responded to a question about whether the product is appropriate for them to use (self-selection), selected participants then entered part 2 where they recieved study product (actual use).
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Part 1 included subjects who answer the self-selection question, probing question and follow-up questions.
Part 2 included subjects who self-selected to use the product, purchase the product and took at least one dose of drug and participate in at least 1 phone interview. | 679 |
| Total | 679 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Eligibility for Part 2 | Eligible but did not enter Part 2 | 20 |
| Part 1, Self-Selection Phase | Withdrawal by Subject | 10 |
| Part 2, Actual-Use Phase | Adverse Event | 6 |
| Part 2, Actual-Use Phase | Lost to Follow-up | 5 |
| Part 2, Actual-Use Phase | Other than reason specified above | 7 |
| Part 2, Actual-Use Phase | Withdrawal by Subject | 21 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 65.7 years STANDARD_DEVIATION 13.2 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 679 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 26 / 679 | 26 / 351 | 22 / 321 |
| serious Total, serious adverse events | 10 / 679 | 10 / 351 | 9 / 321 |
Outcome results
Primary
Percentage of Participants Who Appropriately Followed the Label Instructions
Includes subjects who reported: 1. No improvement in urinary symptoms and stopped taking product, 2. Reported worsening of urinary symptoms and stopped taking the product, 3. Reported a new urinary symptom and stopped taking the product, 4. Reported no Stop Use condition and never took more than 1 capsule on any given day, 5. Reported a Stop Use condition and contacted a provider.
Time frame: 8 weeks
Population: Full Analysis Set for Actual Use Study (FAS-AUS), all subjects who self-selected to use the product, purchased the product, took at least one dose of the product and participated in at least one phone interview.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tamsulosin Hydrochloride | Percentage of Participants Who Appropriately Followed the Label Instructions | 85.4 Percentage of participants |
Secondary
Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase
Includes participants who: 1. were less than 45 years of age at enrollment, and 2. spoke to a doctor during the actual use phase.
Time frame: 8 weeks
Population: Full Analysis Set for Actual Use Study- Under 45 years (FAS-AUS45), all subjects less than 45 years of age who self-selected to use the product, purchased the product, took at least one dose of the product and participated in at least one phone interview
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tamsulosin Hydrochloride | Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase | 30.4 Percentage of participants |
Secondary
Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population
Percentage of participants who are potentially at risk of harm by incorrectly selecting to use the study product out of the total study population
Time frame: 8 weeks
Population: Evaluable Analysis Set for Self-Selection (EVAL-SS), all subjects who answered the self-selection question, probing question and followup questions.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tamsulosin Hydrochloride | Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population | 20.9 Percentage of participants |
Secondary
Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population
Percentage of participants who have a correct self-selection response as defined by the Uses, Allergy alert, and Do Not Use sections of the Drug Facts Label.
Time frame: 8 weeks
Population: Evaluable Analysis Set for Self-Selection (EVAL-SS), all subjects who answered the self-selection question, probing question and followup questions.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tamsulosin Hydrochloride | Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population | 73.9 Percentage of participants |
Secondary
Percentage of Participants Who Took no More Than One Capsule Per Day
Percentage of participants who took no more than one capsule per day
Time frame: 8 weeks
Population: Subjects who completed all three telephone follow-up interviews out of the FAS population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tamsulosin Hydrochloride | Percentage of Participants Who Took no More Than One Capsule Per Day | 93.7 Percentage of participants |
Secondary
Percentage of Use-Days for All Participants Who Took no More Than One Capsule Per Day
Use-day was defind as a calendar day for which data were available regarding use or non-use.
Time frame: 8 weeks
Population: Full Analysis Set for Actual Use Study (FAS-AUS), all subjects who self-selected to use the product, purchased the product, took at least one dose of the product and participated in at least one phone interview
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tamsulosin Hydrochloride | Percentage of Use-Days for All Participants Who Took no More Than One Capsule Per Day | 94.1 Percentage of participants |