Actual Use Study of Tamsulosin in Men

Urological Manifestations Clinical Trial

Official title:

A 6-month OTC-simulated, Open Label, Uncontrolled Study of Tamsulosin 0.4 mg in Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02573311
• Other study ID #: 527.85
• Status: Completed
• Phase: Phase 3
• Start date: September 23, 2015
• Est. completion date: August 1, 2016

Study information

• Verified date: April 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1117
• Est. completion date: August 1, 2016
• Est. primary completion date: August 1, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urological Manifestations

Intervention

Drug:
• tamsulosin hydrochloride

Locations

Country	Name	City	State
United States	Duran Central Pharmacy	Albuquerque	New Mexico
United States	Sam's Regent Pharmacy	Albuquerque	New Mexico
United States	Goodrich Pharmacy	Andover	Minnesota
United States	Parkway Discount Drugs	Birmingham	Alabama
United States	Goodrich Pharmacy	Blaine	Minnesota
United States	Mountain West Apothecary	Bountiful	Utah
United States	Total Care Pharmacy	Burlington	North Carolina
United States	Kroger Pharmacy #342	Cary	North Carolina
United States	Med Center Compounding Pharmacy & Health Center	Cleveland	Tennessee
United States	Sutton Family Pharmacy	Dalton	Georgia
United States	Goodrich Pharmacy	Elk River	Minnesota
United States	Huff's Drug Store	Ellijay	Georgia
United States	The Medicine Shoppe and Elsberry Pharmacy	Elsberry	Missouri
United States	Foothills Compounding Pharmacy	Enumclaw	Washington
United States	Garden Drug	Fort Lauderdale	Florida
United States	Wynn's Pharmacy Incorporated	Griffin	Georgia
United States	Family Care Pharmacy	Highland	Illinois
United States	T.B. Bond Pharmacy	Hillsboro	Texas
United States	Homewood Pharmacy	Homewood	Alabama
United States	Robert's Discount Pharmacy	Hoover	Alabama
United States	Eagle Pharmacy	Houston	Texas
United States	Albers' Specialty Pharmacy	Kansas City	Missouri
United States	Maple Mountain Pharmacy	Mapleton	Utah
United States	Pharmacy at the Pig	McCalla	Alabama
United States	Texas Road Pharmacy	Monroe	New Jersey
United States	Northfield Pharmacy	Northfield	Minnesota
United States	The Medicine Shoppe	Ogden	Utah
United States	Pill Box Pharmacy	Pembroke Pines	Florida
United States	Pinson Discount Drugs	Pinson	Alabama
United States	Parkview Compounding Pharmacy	Rancho Cucamonga	California
United States	Apex Specialty Pharmacy	Riverside	Missouri
United States	Stevenson Family Pharmacy	Saint Joseph	Missouri
United States	Cub Pharmacy #1924	Saint Louis Park	Minnesota
United States	Countryside Pharmacy	Savannah	Missouri
United States	Kelley-Ross Compounding Pharmacy	Seattle	Washington
United States	Rxtra Care	Seattle	Washington
United States	Kusler's Compounding Pharmacy	Snohomish	Washington
United States	Charleston Pharmacy, South Charleston	South Charleston	Ohio
United States	ACACIA Apothecary and Wellness	Tucson	Arizona
United States	Family Plaza Pharmacy	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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.	24 weeks
Secondary	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.	Week 12
Secondary	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.	Week 24
Secondary	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	12 weeks
Secondary	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.	24 weeks
Secondary	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.	24 weeks
Secondary	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	Week 12 and Week 24
Secondary	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	Week 12 and Week 24

External Links

•   Synopsis Link