Clinical trial NCT02573311: Actual Use Study of Tamsulosin in Men
Official title: A 6-month OTC-simulated, Open Label, Uncontrolled Study of Tamsulosin 0.4 mg in Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urological Manifestations
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-10-09
Enrollment: 1117
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An actual use study to assess how men who respond to advertisements about urinary symptoms use tamsulosin in a simulated Over the Counter (OTC) setting including following "stop use and ask a doctor if" and "ask a doctor before use" statements and if they take the medication according to the label instructions, also assess any reported adverse events during simulated OTC use.


Eligibility criteria: Inclusion criteria:

* Men, 18 years of age and older, with bothersome urinary symptoms
* Able to speak, read and understand English
* Subject or anyone in their household is not currently employed by a marketing or marketing research company, advertising agency or public relations firm, a pharmacy or pharmaceutical company, a manufacturer of medicines, a managed care or health insurance company, as a certified or licensed healthcare professional or in a healthcare practice
* Has not participated in any clinical trial in the last 12 months
* Willing to sign an informed consent/HIPPA form and willing and able to provide contact information

Exclusion criteria:

* Allergy to tamsulosin hydrochloride or sulpha drugs
* Report current use of a medication listed on the "Do not use" section of the Drug Facts Label (DFL)
* Choose not to purchase the study product
* Do not provide consent or sign HIPPA form
* Do not provide contact information

Primary outcomes:
measure: Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL Within the First 12 Weeks of Using Study Product and do Not Stop Use or Initiate Contact With Doctor Out of Total Population in Cohort 1
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL During the Study (24 Weeks) and do Not Stop Use or Initiate Contact With a Doctor Out of the Total Population in Cohort 1
timeFrame: 24 weeks
measure: Percentage of Men Who Report Condition Listed Under "Stop Use and Ask a Doctor if" Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 12 Weeks
timeFrame: Week 12
measure: Percentage of Men Who Report Condition Listed Under "Stop Use and Ask a Doctor if" Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 24 Weeks
timeFrame: Week 24
measure: Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL Within the First 12 Weeks of Using Study Product Out of the Total Population in Cohort 1
timeFrame: 12 weeks
measure: Percentage of Men Who Report at Baseline a Symptom or Condition Under the "Ask A Doctor Before Use" Section of the DFL and Initiate Contact With a Doctor Out of the Total Population in Cohort 1
timeFrame: 24 weeks
measure: Percentage of Men Who Report at Baseline a Symptom or Condition Under the "Ask A Doctor Before Use" Section of the DFL and Initiate Contact With a Doctor Out of the Total Population of Cohort 1 Who Report a Symptom or Condition
timeFrame: 24 weeks
measure: Percentage of Men Who Seek the Advice of a Physician Within the First 12/24 Weeks of the Study Out of the Total Population in Cohort 1
timeFrame: Week 12 and Week 24
measure: Percentage of Men Who Took Two or More Capsules Per Day Within the First 12/24 Weeks of Using Study Product Out of the Total Population in Cohort 1
timeFrame: Week 12 and Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Parkway Discount Drugs
state: Alabama
city: Homewood
country: United States
facility: Homewood Pharmacy
state: Alabama
city: Hoover
country: United States
facility: Robert's Discount Pharmacy
state: Alabama
city: McCalla
country: United States
facility: Pharmacy at the Pig
state: Alabama
city: Pinson
country: United States
facility: Pinson Discount Drugs
state: Alabama
city: Tucson
country: United States
facility: ACACIA Apothecary and Wellness
state: Arizona
city: Rancho Cucamonga
country: United States
facility: Parkview Compounding Pharmacy
state: California
city: Fort Lauderdale
country: United States
facility: Garden Drug
state: Florida
city: Pembroke Pines
country: United States
facility: Pill Box Pharmacy
state: Florida
city: Dalton
country: United States
facility: Sutton Family Pharmacy
state: Georgia
city: Ellijay
country: United States
facility: Huff's Drug Store
state: Georgia
city: Griffin
country: United States
facility: Wynn's Pharmacy Incorporated
state: Georgia
city: Highland
country: United States
facility: Family Care Pharmacy
state: Illinois
city: Andover
country: United States
facility: Goodrich Pharmacy
state: Minnesota
city: Blaine
country: United States
facility: Goodrich Pharmacy
state: Minnesota
city: Elk River
country: United States
facility: Goodrich Pharmacy
state: Minnesota
city: Northfield
country: United States
facility: Northfield Pharmacy
state: Minnesota
city: Saint Louis Park
country: United States
facility: Cub Pharmacy #1924
state: Minnesota
city: Elsberry
country: United States
facility: The Medicine Shoppe and Elsberry Pharmacy
state: Missouri
city: Kansas City
country: United States
facility: Albers' Specialty Pharmacy
state: Missouri
city: Riverside
country: United States
facility: Apex Specialty Pharmacy
state: Missouri
city: Saint Joseph
country: United States
facility: Stevenson Family Pharmacy
state: Missouri
city: Savannah
country: United States
facility: Countryside Pharmacy
state: Missouri
city: Monroe
country: United States
facility: Texas Road Pharmacy
state: New Jersey
city: Albuquerque
country: United States
facility: Duran Central Pharmacy
state: New Mexico
city: Albuquerque
country: United States
facility: Sam's Regent Pharmacy
state: New Mexico
city: Burlington
country: United States
facility: Total Care Pharmacy
state: North Carolina
city: Cary
country: United States
facility: Kroger Pharmacy #342
state: North Carolina
city: South Charleston
country: United States
facility: Charleston Pharmacy, South Charleston
state: Ohio
city: Cleveland
country: United States
facility: Med Center Compounding Pharmacy & Health Center
state: Tennessee
city: Hillsboro
country: United States
facility: T.B. Bond Pharmacy
state: Texas
city: Houston
country: United States
facility: Eagle Pharmacy
state: Texas
city: Bountiful
country: United States
facility: Mountain West Apothecary
state: Utah
city: Mapleton
country: United States
facility: Maple Mountain Pharmacy
state: Utah
city: Ogden
country: United States
facility: The Medicine Shoppe
state: Utah
city: West Jordan
country: United States
facility: Family Plaza Pharmacy
state: Utah
city: Enumclaw
country: United States
facility: Foothills Compounding Pharmacy
state: Washington
city: Seattle
country: United States
facility: Kelley-Ross Compounding Pharmacy
state: Washington
city: Seattle
country: United States
facility: Rxtra Care
state: Washington
city: Snohomish
country: United States
facility: Kusler's Compounding Pharmacy
state: Washington
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: