Clinical trial NCT01726270: An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms
Official title: A 8-week, Open-label, Uncontrolled, Exploratory Actual Use Study of Tamsulosin 0.4mg in Men With Prostate Urinary Symptoms in a Simulated Over-the-Counter Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lower Urinary Tract Symptoms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-11-14
Enrollment: 689
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multicenter trial conducted in Pharmacy retail centers


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Appropriately Followed the Label Instructions
timeFrame: 8 weeks
Secondary outcomes:
measure: Percentage of Participants Who Took no More Than One Capsule Per Day
timeFrame: 8 weeks
measure: Percentage of "Use-Days" for All Participants Who Took no More Than One Capsule Per Day
timeFrame: 8 weeks
measure: Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase
timeFrame: 8 weeks
measure: Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population
timeFrame: 8 weeks
measure: Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Alabama
city: Mesa
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Arizona
city: Encino
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Garden Grove
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: La Habra
country: United States
facility: Boehringer Ingelheim Investigational Site
state: California
city: Anoka
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Minnesota
city: Elk River
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Minnesota
city: Fridley
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Minnesota
city: Roseville
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Minnesota
city: Saint Francis
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Minnesota
city: Albuquerque
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New Mexico
city: Longview
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Tyler
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Texas
city: Bountiful
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Utah
city: Layton
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Utah
city: Syracuse
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Utah
city: Richmond
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Virginia
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Roehrborn CG, Lowe FC, Gittelman M, Wruck JM, Verbeek AE. Management of Male Lower Urinary Tract Symptoms in a Simulated, Over-the-Counter Setting: An Exploratory Study of Tamsulosin. Drugs Aging. 2019 Feb;36(2):179-188. doi: 10.1007/s40266-018-0621-8.