An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms

Lower Urinary Tract Symptoms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726270
• Other study ID #: 527.82
• Status: Completed
• Phase: Phase 2
• Start date: November 2012
• Est. completion date: March 2013

Study information

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

Clinical Trial Summary

Multicenter trial conducted in Pharmacy retail centers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 689
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Intervention

Drug:
• tamsulosin
0.4 mg

Locations

Country	Name	City	State
United States	Boehringer Ingelheim Investigational Site	Albuquerque	New Mexico
United States	Boehringer Ingelheim Investigational Site	Anoka	Minnesota
United States	Boehringer Ingelheim Investigational Site	Bountiful	Utah
United States	Boehringer Ingelheim Investigational Site	Elk River	Minnesota
United States	Boehringer Ingelheim Investigational Site	Encino	California
United States	Boehringer Ingelheim Investigational Site	Fridley	Minnesota
United States	Boehringer Ingelheim Investigational Site	Garden Grove	California
United States	Boehringer Ingelheim Investigational Site	Hoover	Alabama
United States	Boehringer Ingelheim Investigational Site	La Habra	California
United States	Boehringer Ingelheim Investigational Site	Layton	Utah
United States	Boehringer Ingelheim Investigational Site	Longview	Texas
United States	Boehringer Ingelheim Investigational Site	Mesa	Arizona
United States	Boehringer Ingelheim Investigational Site	Richmond	Virginia
United States	Boehringer Ingelheim Investigational Site	Roseville	Minnesota
United States	Boehringer Ingelheim Investigational Site	Saint Francis	Minnesota
United States	Boehringer Ingelheim Investigational Site	Salt Lake City	Utah
United States	Boehringer Ingelheim Investigational Site	Syracuse	Utah
United States	Boehringer Ingelheim Investigational Site	Tyler	Texas

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 Participants Who Appropriately Followed the Label Instructions	Includes subjects who reported: No improvement in urinary symptoms and stopped taking product,; Reported worsening of urinary symptoms and stopped taking the product,; Reported a new urinary symptom and stopped taking the product,; Reported no "Stop Use" condition and never took more than 1 capsule on any given day,; Reported a "Stop Use" condition and contacted a provider.	8 weeks
Secondary	Percentage of Participants Who Took no More Than One Capsule Per Day	Percentage of participants who took no more than one capsule per day	8 weeks
Secondary	Percentage of "Use-Days" for All Participants Who Took no More Than One Capsule Per Day	"Use-day" was defind as a calendar day for which data were available regarding use or non-use.	8 weeks
Secondary	Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase	Includes participants who: were less than 45 years of age at enrollment, and; spoke to a doctor during the actual use phase.	8 weeks
Secondary	Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population	Percentage of participants who are potentially at risk of harm by incorrectly selecting to use the study product out of the total study population	8 weeks
Secondary	Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population	Percentage of participants who have a correct self-selection response as defined by the "Uses", "Allergy alert", and "Do Not Use" sections of the Drug Facts Label.	8 weeks

External Links

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