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OpenTrials
Completed

NCT Number: NCT01726270

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

Multicenter trial conducted in Pharmacy retail centers

Completed

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Key information

Conditions

Lower Urinary Tract Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Boehringer Ingelheim Investigational Site, Hoover, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Tamsulosin

Drug

0.4 mg

Primary outcomes

  1. Percentage of Participants Who Appropriately Followed the Label Instructions

    Time frame: 8 weeks

    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 outcomes

  1. 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

  2. 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.

  3. Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase

    Time frame: 8 weeks

    Includes participants who:

    • were less than 45 years of age at enrollment, and
    • spoke to a doctor during the actual use phase.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 14, 2012
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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