Actual Use Study of Tamsulosin in Men

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Urological Manifestations

Treatments: Drug: tamsulosin hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT02573311

527.85

Details and patient eligibility

About

An actual use study to assess how men who respond to advertisements about urinary symptoms use tamsulosin in a simulated Over the Counter (OTC) setting including following "stop use and ask a doctor if" and "ask a doctor before use" statements and if they take the medication according to the label instructions, also assess any reported adverse events during simulated OTC use.

Enrollment: 1,117 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men, 18 years of age and older, with bothersome urinary symptoms
• Able to speak, read and understand English
• Subject or anyone in their household is not currently employed by a marketing or marketing research company, advertising agency or public relations firm, a pharmacy or pharmaceutical company, a manufacturer of medicines, a managed care or health insurance company, as a certified or licensed healthcare professional or in a healthcare practice
• Has not participated in any clinical trial in the last 12 months
• Willing to sign an informed consent/HIPPA form and willing and able to provide contact information

Exclusion criteria

• Allergy to tamsulosin hydrochloride or sulpha drugs
• Report current use of a medication listed on the "Do not use" section of the Drug Facts Label (DFL)
• Choose not to purchase the study product
• Do not provide consent or sign HIPPA form
• Do not provide contact information

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,117 participants in 1 patient group

men

Experimental group

Treatment:

Drug: tamsulosin hydrochloride