- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02573311
Actual Use Study of Tamsulosin in Men
April 6, 2020 updated by: Boehringer Ingelheim
A 6-month OTC-simulated, Open Label, Uncontrolled Study of Tamsulosin 0.4 mg in Men
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1117
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35215
- Parkway Discount Drugs
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Homewood, Alabama, United States, 35209
- Homewood Pharmacy
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Hoover, Alabama, United States, 35226
- Robert's Discount Pharmacy
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McCalla, Alabama, United States, 35111
- Pharmacy at the Pig
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Pinson, Alabama, United States, 35126
- Pinson Discount Drugs
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Arizona
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Tucson, Arizona, United States, 85704
- ACACIA Apothecary and Wellness
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California
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Rancho Cucamonga, California, United States, 91730
- Parkview Compounding Pharmacy
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Florida
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Fort Lauderdale, Florida, United States, 33309
- Garden Drug
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Pembroke Pines, Florida, United States, 33026
- Pill Box Pharmacy
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Georgia
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Dalton, Georgia, United States, 30721
- Sutton Family Pharmacy
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Ellijay, Georgia, United States, 30540
- Huff's Drug Store
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Griffin, Georgia, United States, 30224
- Wynn's Pharmacy Incorporated
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Illinois
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Highland, Illinois, United States, 62249
- Family Care Pharmacy
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Minnesota
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Andover, Minnesota, United States, 55304
- Goodrich Pharmacy
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Blaine, Minnesota, United States, 55434
- Goodrich Pharmacy
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Elk River, Minnesota, United States, 55330
- Goodrich Pharmacy
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Northfield, Minnesota, United States, 55057
- Northfield Pharmacy
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Saint Louis Park, Minnesota, United States, 55426
- Cub Pharmacy #1924
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Missouri
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Elsberry, Missouri, United States, 63343
- The Medicine Shoppe and Elsberry Pharmacy
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Kansas City, Missouri, United States, 64111
- Albers' Specialty Pharmacy
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Riverside, Missouri, United States, 64150
- Apex Specialty Pharmacy
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Saint Joseph, Missouri, United States, 64504
- Stevenson Family Pharmacy
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Savannah, Missouri, United States, 64485
- Countryside Pharmacy
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New Jersey
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Monroe, New Jersey, United States, 08831
- Texas Road Pharmacy
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New Mexico
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Albuquerque, New Mexico, United States, 87104
- Duran Central Pharmacy
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Albuquerque, New Mexico, United States, 87109
- Sam's Regent Pharmacy
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North Carolina
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Burlington, North Carolina, United States, 27215
- Total Care Pharmacy
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Cary, North Carolina, United States, 27513
- Kroger Pharmacy #342
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Ohio
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South Charleston, Ohio, United States, 45368
- Charleston Pharmacy, South Charleston
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Tennessee
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Cleveland, Tennessee, United States, 37311
- Med Center Compounding Pharmacy & Health Center
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Texas
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Hillsboro, Texas, United States, 76645
- T.B. Bond Pharmacy
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Houston, Texas, United States, 77099
- Eagle Pharmacy
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Utah
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Bountiful, Utah, United States, 84010
- Mountain West Apothecary
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Mapleton, Utah, United States, 84664
- Maple Mountain Pharmacy
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Ogden, Utah, United States, 84401
- The Medicine Shoppe
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West Jordan, Utah, United States, 84088
- Family Plaza Pharmacy
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Washington
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Enumclaw, Washington, United States, 98022
- Foothills Compounding Pharmacy
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Seattle, Washington, United States, 98104
- Kelley-Ross Compounding Pharmacy
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Seattle, Washington, United States, 98115
- Rxtra Care
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Snohomish, Washington, United States, 98290
- Kusler's Compounding Pharmacy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: men
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 12 weeks
|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 24 weeks
|
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.
|
24 weeks
|
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
Time Frame: Week 12
|
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.
|
Week 12
|
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
Time Frame: Week 24
|
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.
|
Week 24
|
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
Time Frame: 12 weeks
|
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
|
12 weeks
|
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
Time Frame: 24 weeks
|
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.
|
24 weeks
|
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
Time Frame: 24 weeks
|
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.
|
24 weeks
|
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
Time Frame: Week 12 and Week 24
|
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
|
Week 12 and Week 24
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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
Time Frame: Week 12 and Week 24
|
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
|
Week 12 and Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 23, 2015
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
October 1, 2015
First Submitted That Met QC Criteria
October 8, 2015
First Posted (Estimate)
October 9, 2015
Study Record Updates
Last Update Posted (Actual)
April 8, 2020
Last Update Submitted That Met QC Criteria
April 6, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 527.85
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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