search
Back to results

Actual Use Study of Tamsulosin in Men

Primary Purpose

Urological Manifestations

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
tamsulosin hydrochloride
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urological Manifestations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Parkway Discount Drugs
  • Homewood Pharmacy
  • Robert's Discount Pharmacy
  • Pharmacy at the Pig
  • Pinson Discount Drugs
  • ACACIA Apothecary and Wellness
  • Parkview Compounding Pharmacy
  • Garden Drug
  • Pill Box Pharmacy
  • Sutton Family Pharmacy
  • Huff's Drug Store
  • Wynn's Pharmacy Incorporated
  • Family Care Pharmacy
  • Goodrich Pharmacy
  • Goodrich Pharmacy
  • Goodrich Pharmacy
  • Northfield Pharmacy
  • Cub Pharmacy #1924
  • The Medicine Shoppe and Elsberry Pharmacy
  • Albers' Specialty Pharmacy
  • Apex Specialty Pharmacy
  • Stevenson Family Pharmacy
  • Countryside Pharmacy
  • Texas Road Pharmacy
  • Duran Central Pharmacy
  • Sam's Regent Pharmacy
  • Total Care Pharmacy
  • Kroger Pharmacy #342
  • Charleston Pharmacy, South Charleston
  • Med Center Compounding Pharmacy & Health Center
  • T.B. Bond Pharmacy
  • Eagle Pharmacy
  • Mountain West Apothecary
  • Maple Mountain Pharmacy
  • The Medicine Shoppe
  • Family Plaza Pharmacy
  • Foothills Compounding Pharmacy
  • Kelley-Ross Compounding Pharmacy
  • Rxtra Care
  • Kusler's Compounding Pharmacy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

men

Arm Description

Outcomes

Primary Outcome Measures

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
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the Drug Facts Label (DFL) within the first 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population is presented along with 95% exact two sided Clopper-Pearson confidence interval.

Secondary Outcome Measures

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
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL during the study (i.e., 24 weeks) and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval.
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
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 12 weeks of using study product is presented along with 95% exact two sided Clopper-Pearson confidence interval.
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
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 24 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 24 weeks of using study product is presented along with 95% exact two sided Clopper-Pearson confidence interval.
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
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within the first 12 weeks of using the study product out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval
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
Percentage of men who reported at baseline a symptom or condition under the "Ask A Doctor Before Use" section of the DFL and initiated contact with a doctor out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval.
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
Percentage of men who reported at baseline a symptom or condition under the "Ask A Doctor Before Use" section of the DFL and initiated contact with a doctor out of the total population of men in Cohort 1 who reported a symptom or condition is presented along with 95% exact two sided Clopper-Pearson confidence interval.
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
Percentage of men who sought advice of a physician within the first 12/24 weeks of the study out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval
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
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 of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval

Full Information

First Posted
October 1, 2015
Last Updated
April 6, 2020
Sponsor
Boehringer Ingelheim
search

1. Study Identification

Unique Protocol Identification Number
NCT02573311
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 23, 2015 (Actual)
Primary Completion Date
August 1, 2016 (Actual)
Study Completion Date
August 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urological Manifestations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
men
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
tamsulosin hydrochloride
Primary Outcome Measure Information:
Title
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
Description
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the Drug Facts Label (DFL) within the first 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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
Description
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL during the study (i.e., 24 weeks) and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Time Frame
24 weeks
Title
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
Description
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 12 weeks of using study product is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Time Frame
Week 12
Title
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
Description
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 24 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 24 weeks of using study product is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Time Frame
Week 24
Title
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
Description
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within the first 12 weeks of using the study product out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval
Time Frame
12 weeks
Title
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
Description
Percentage of men who reported at baseline a symptom or condition under the "Ask A Doctor Before Use" section of the DFL and initiated contact with a doctor out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Time Frame
24 weeks
Title
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
Description
Percentage of men who reported at baseline a symptom or condition under the "Ask A Doctor Before Use" section of the DFL and initiated contact with a doctor out of the total population of men in Cohort 1 who reported a symptom or condition is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Time Frame
24 weeks
Title
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
Description
Percentage of men who sought advice of a physician within the first 12/24 weeks of the study out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval
Time Frame
Week 12 and Week 24
Title
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
Description
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 of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval
Time Frame
Week 12 and Week 24

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
Parkway Discount Drugs
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
Homewood Pharmacy
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Robert's Discount Pharmacy
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35226
Country
United States
Facility Name
Pharmacy at the Pig
City
McCalla
State/Province
Alabama
ZIP/Postal Code
35111
Country
United States
Facility Name
Pinson Discount Drugs
City
Pinson
State/Province
Alabama
ZIP/Postal Code
35126
Country
United States
Facility Name
ACACIA Apothecary and Wellness
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Parkview Compounding Pharmacy
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Garden Drug
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
Pill Box Pharmacy
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Sutton Family Pharmacy
City
Dalton
State/Province
Georgia
ZIP/Postal Code
30721
Country
United States
Facility Name
Huff's Drug Store
City
Ellijay
State/Province
Georgia
ZIP/Postal Code
30540
Country
United States
Facility Name
Wynn's Pharmacy Incorporated
City
Griffin
State/Province
Georgia
ZIP/Postal Code
30224
Country
United States
Facility Name
Family Care Pharmacy
City
Highland
State/Province
Illinois
ZIP/Postal Code
62249
Country
United States
Facility Name
Goodrich Pharmacy
City
Andover
State/Province
Minnesota
ZIP/Postal Code
55304
Country
United States
Facility Name
Goodrich Pharmacy
City
Blaine
State/Province
Minnesota
ZIP/Postal Code
55434
Country
United States
Facility Name
Goodrich Pharmacy
City
Elk River
State/Province
Minnesota
ZIP/Postal Code
55330
Country
United States
Facility Name
Northfield Pharmacy
City
Northfield
State/Province
Minnesota
ZIP/Postal Code
55057
Country
United States
Facility Name
Cub Pharmacy #1924
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
The Medicine Shoppe and Elsberry Pharmacy
City
Elsberry
State/Province
Missouri
ZIP/Postal Code
63343
Country
United States
Facility Name
Albers' Specialty Pharmacy
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Apex Specialty Pharmacy
City
Riverside
State/Province
Missouri
ZIP/Postal Code
64150
Country
United States
Facility Name
Stevenson Family Pharmacy
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64504
Country
United States
Facility Name
Countryside Pharmacy
City
Savannah
State/Province
Missouri
ZIP/Postal Code
64485
Country
United States
Facility Name
Texas Road Pharmacy
City
Monroe
State/Province
New Jersey
ZIP/Postal Code
08831
Country
United States
Facility Name
Duran Central Pharmacy
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87104
Country
United States
Facility Name
Sam's Regent Pharmacy
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Total Care Pharmacy
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
Country
United States
Facility Name
Kroger Pharmacy #342
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27513
Country
United States
Facility Name
Charleston Pharmacy, South Charleston
City
South Charleston
State/Province
Ohio
ZIP/Postal Code
45368
Country
United States
Facility Name
Med Center Compounding Pharmacy & Health Center
City
Cleveland
State/Province
Tennessee
ZIP/Postal Code
37311
Country
United States
Facility Name
T.B. Bond Pharmacy
City
Hillsboro
State/Province
Texas
ZIP/Postal Code
76645
Country
United States
Facility Name
Eagle Pharmacy
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Mountain West Apothecary
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Maple Mountain Pharmacy
City
Mapleton
State/Province
Utah
ZIP/Postal Code
84664
Country
United States
Facility Name
The Medicine Shoppe
City
Ogden
State/Province
Utah
ZIP/Postal Code
84401
Country
United States
Facility Name
Family Plaza Pharmacy
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Foothills Compounding Pharmacy
City
Enumclaw
State/Province
Washington
ZIP/Postal Code
98022
Country
United States
Facility Name
Kelley-Ross Compounding Pharmacy
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Rxtra Care
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Facility Name
Kusler's Compounding Pharmacy
City
Snohomish
State/Province
Washington
ZIP/Postal Code
98290
Country
United States

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com
Description
Synopsis Link

Learn more about this trial

Actual Use Study of Tamsulosin in Men

We'll reach out to this number within 24 hrs