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

Phase 2CompletedNCT01726270

Boehringer Ingelheim689 enrolled

Overview

Multicenter trial conducted in Pharmacy retail centers

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

689

Conditions

Lower Urinary Tract Symptoms

Interventions

tamsulosinDRUG

0.4 mg

Eligibility

Sex: MALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (18)

Boehringer Ingelheim Investigational Site

Hoover, Alabama, United States

Boehringer Ingelheim Investigational Site

Mesa, Arizona, United States

Outcomes

Primary Outcomes

Percentage of Participants Who Appropriately Followed the Label Instructions

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.

Time frame: 8 weeks

Secondary Outcomes

Percentage of Participants Who Took no More Than One Capsule Per Day

Percentage of participants who took no more than one capsule per day

Time frame: 8 weeks

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.

Time frame: 8 weeks

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

Includes participants who: 1. were less than 45 years of age at enrollment, and 2. spoke to a doctor during the actual use phase.

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

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 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.

Data from ClinicalTrials.gov

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