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

March 12, 2020 updated by: Boehringer Ingelheim

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

Multicenter trial conducted in Pharmacy retail centers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

689

Phase

  • Phase 2

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

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

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

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: tamsulosin hydrochloride
patients will take drug for 8 weeks in this exploratory study
Drug: tamsulosin
0.4 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Appropriately Followed the Label Instructions
Time Frame: 8 weeks

Includes subjects who reported:

  1. No improvement in urinary symptoms and stopped taking product,
  2. Reported worsening of urinary symptoms and stopped taking the product,
  3. Reported a new urinary symptom and stopped taking the product,
  4. Reported no "Stop Use" condition and never took more than 1 capsule on any given day,
  5. Reported a "Stop Use" condition and contacted a provider.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Took no More Than One Capsule Per Day
Time Frame: 8 weeks
Percentage of participants who took no more than one capsule per day
8 weeks
Percentage of "Use-Days" for All Participants Who Took no More Than One Capsule Per Day
Time Frame: 8 weeks
"Use-day" was defind as a calendar day for which data were available regarding use or non-use.
8 weeks
Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase
Time Frame: 8 weeks

Includes participants who:

  1. were less than 45 years of age at enrollment, and
  2. spoke to a doctor during the actual use phase.
8 weeks
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
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
Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population
Time Frame: 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

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.

General Publications

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

November 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 9, 2012

First Submitted That Met QC Criteria

November 9, 2012

First Posted (Estimate)

November 14, 2012

Study Record Updates

Last Update Posted (Actual)

March 27, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 527.82

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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