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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01726270
First received: November 9, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

Multicenter trial conducted in Pharmacy retail centers


Condition Intervention Phase
Lower Urinary Tract Symptoms
Drug: tamsulosin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The primary objective was to collect preliminary self-reported behavioral data on actual use of the product that will inform the design of a pivotal Actual Use study. [ Time Frame: <please enter timeframe> ] [ Designated as safety issue: No ]

Enrollment: 689
Study Start Date: November 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tamsulosin hydrochloride
patients will take drug for 8 weeks in this exploratory study
Drug: tamsulosin
0.4 mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726270

Locations
United States, Alabama
527.82.170 Boehringer Ingelheim Investigational Site
Hoover, Alabama, United States
United States, Arizona
527.82.167 Boehringer Ingelheim Investigational Site
Mesa, Arizona, United States
United States, California
527.82.177 Boehringer Ingelheim Investigational Site
Encino, California, United States
527.82.168 Boehringer Ingelheim Investigational Site
Garden Grove, California, United States
527.82.171 Boehringer Ingelheim Investigational Site
La Habra, California, United States
United States, Minnesota
527.82.161 Boehringer Ingelheim Investigational Site
Anoka, Minnesota, United States
527.82.179 Boehringer Ingelheim Investigational Site
Elk River, Minnesota, United States
527.82.163 Boehringer Ingelheim Investigational Site
Fridley, Minnesota, United States
527.82.165 Boehringer Ingelheim Investigational Site
Roseville, Minnesota, United States
527.82.166 Boehringer Ingelheim Investigational Site
St. Francis, Minnesota, United States
United States, New Mexico
527.82.176 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico, United States
United States, Texas
527.82.181 Boehringer Ingelheim Investigational Site
Longview, Texas, United States
527.82.160 Boehringer Ingelheim Investigational Site
Tyler, Texas, United States
United States, Utah
527.82.162 Boehringer Ingelheim Investigational Site
Bountiful, Utah, United States
527.82.180 Boehringer Ingelheim Investigational Site
Layton, Utah, United States
527.82.173 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
527.82.174 Boehringer Ingelheim Investigational Site
Syracuse, Utah, United States
United States, Virginia
527.82.169 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01726270     History of Changes
Other Study ID Numbers: 527.82
Study First Received: November 9, 2012
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014