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

Primary Purpose

Lower Urinary Tract Symptoms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tamsulosin
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptoms

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tamsulosin hydrochloride

Arm Description

patients will take drug for 8 weeks in this exploratory study

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants Who Took no More Than One Capsule Per Day
Percentage of participants who took no more than one capsule per day
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.
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.
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
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.

Full Information

First Posted
November 9, 2012
Last Updated
March 12, 2020
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01726270
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Multicenter trial conducted in Pharmacy retail centers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
689 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tamsulosin hydrochloride
Arm Type
Experimental
Arm Description
patients will take drug for 8 weeks in this exploratory study
Intervention Type
Drug
Intervention Name(s)
tamsulosin
Intervention Description
0.4 mg
Primary Outcome Measure Information:
Title
Percentage of Participants Who Appropriately Followed the Label Instructions
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Took no More Than One Capsule Per Day
Description
Percentage of participants who took no more than one capsule per day
Time Frame
8 weeks
Title
Percentage of "Use-Days" for All Participants Who Took no More Than One Capsule Per Day
Description
"Use-day" was defind as a calendar day for which data were available regarding use or non-use.
Time Frame
8 weeks
Title
Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase
Description
Includes participants who: were less than 45 years of age at enrollment, and spoke to a doctor during the actual use phase.
Time Frame
8 weeks
Title
Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population
Description
Percentage of participants who are potentially at risk of harm by incorrectly selecting to use the study product out of the total study population
Time Frame
8 weeks
Title
Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Men 18 years of age and older. Able to speak, read and understand English. 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.
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
Boehringer Ingelheim Investigational Site
City
Hoover
State/Province
Alabama
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Encino
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Garden Grove
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
La Habra
State/Province
California
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Anoka
State/Province
Minnesota
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Elk River
State/Province
Minnesota
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Fridley
State/Province
Minnesota
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Roseville
State/Province
Minnesota
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Saint Francis
State/Province
Minnesota
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Longview
State/Province
Texas
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Tyler
State/Province
Texas
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Bountiful
State/Province
Utah
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Layton
State/Province
Utah
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Syracuse
State/Province
Utah
Country
United States
Facility Name
Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30607798
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.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info

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

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