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

Phase 2

Completed

• Conditions: Lower Urinary Tract Symptoms
• Interventions: Drug: tamsulosin

• Registration Number: NCT01726270
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Multicenter trial conducted in Pharmacy retail centers

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-09
• Study First Submitted QC: 2012-11-09
• Study First Posted: 2012-11-14
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Disposition First Submitted: 2014-03-25
• Disposition First Submitted QC: 2014-03-25
• Disposition First Posted: 2014-04-21
• Status Verified: 2020-03
• Results First Submitted: 2020-03-12
• Results First Submitted QC: 2020-03-12
• Last Update Submitted: 2020-03-12
• Results First Posted: 2020-03-27
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 689

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tamsulosin hydrochloride	tamsulosin	patients will take drug for 8 weeks in this exploratory study

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Appropriately Followed the Label Instructions	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of "Use-Days" for All Participants Who Took no More Than One Capsule Per Day	8 weeks	"Use-day" was defind as a calendar day for which data were available regarding use or non-use.
Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase	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.
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 are potentially at risk of harm by incorrectly selecting to use the study product out of the total study population
Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population	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.
Percentage of Participants Who Took no More Than One Capsule Per Day	8 weeks	Percentage of participants who took no more than one capsule per day

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇺🇸 Richmond, Virginia, United States