Lower Urinary Tract SymptomsPhase 2NCT01726270

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

A Phase 2 study testing tamsulosin in people with Lower Urinary Tract Symptoms, run by Boehringer Ingelheim at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Multicenter trial conducted in Pharmacy retail centers Read more about this study

Who is it for?: Ages 18 to 100 years, men only
Conditions the study is for: Lower Urinary Tract Symptoms
What is being tested?: tamsulosin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 689 participants
Where: 18 sitesUnited States
Study dates: Nov 2012to Mar 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
Boehringer Ingelheim Investigational Site
Anoka, Minnesota
Boehringer Ingelheim Investigational Site
Bountiful, Utah
Boehringer Ingelheim Investigational Site
Elk River, Minnesota
Boehringer Ingelheim Investigational Site
Encino, California
Boehringer Ingelheim Investigational Site
Fridley, Minnesota
Boehringer Ingelheim Investigational Site
Garden Grove, California
Boehringer Ingelheim Investigational Site
Hoover, Alabama
Boehringer Ingelheim Investigational Site
La Habra, California
Boehringer Ingelheim Investigational Site
Layton, Utah
Boehringer Ingelheim Investigational Site
Longview, Texas
Boehringer Ingelheim Investigational Site
Mesa, Arizona
Boehringer Ingelheim Investigational Site
Richmond, Virginia
Boehringer Ingelheim Investigational Site
Roseville, Minnesota
Boehringer Ingelheim Investigational Site
Saint Francis, Minnesota
Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
Boehringer Ingelheim Investigational Site
Syracuse, Utah
Boehringer Ingelheim Investigational Site
Tyler, Texas

Other trials in United States

About this study

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

Multicenter trial conducted in Pharmacy retail centers

Conditions: Lower Urinary Tract Symptoms
Being tested: tamsulosin
Medical subject headings: Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tamsulosinDrug
0.4 mg

Study groups in NCT01726270
Study group	Role	What they receive
tamsulosin hydrochloride	Experimental	patients will take drug for 8 weeks in this exploratory study Receives: Drug: tamsulosin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 8 weeks

Secondary outcomes (5)

Percentage of Participants Who Took no More Than One Capsule Per Day
Percentage of participants who took no more than one capsule per day
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Mar 2013

First posted14 Nov 2012 (estimated)
Study startNov 2012
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 689 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01726270
Sponsor's protocol ID: 527.82
Status last verified: Mar 2020
First submitted: 9 Nov 2012
Last updated: 27 Mar 2020
Results posted: Yes, on ClinicalTrials.gov

Publications

Roehrborn CG, Lowe FC, Gittelman M, Wruck JM, Verbeek AE. Management of Male Lower Urinary Tract Symptoms in a Simulated, Over-the-Counter Setting: An Exploratory Study of Tamsulosin. Drugs Aging. 2019 Feb;36(2):179-188. doi: 10.1007/s40266-018-0621-8.
PubMed 30607798

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lower Urinary Tract Symptoms trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01726270
Acronym / sponsor ID: 527.82
Conditions: Lower Urinary Tract Symptoms
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 689 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 14 Nov 2012 (estimated)
Results: Posted 27 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Multicenter trial conducted in Pharmacy retail centers

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
tamsulosin hydrochloride	Experimental	Drug: tamsulosinpatients will take drug for 8 weeks in this exploratory study

Who may qualify

Ages: 18 to 100 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tamsulosin0.4 mg	Drug	tamsulosin hydrochloride

Primary outcome

Percentage of Participants Who Appropriately Followed the Label Instructions
Time frame: 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.

5 secondary outcomes

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
Time frame: 8 weeks
Percentage of Participants < 45 Years of Age Who 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
Time frame: 8 weeks
Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population
Time frame: 8 weeks

Results and safety

Results posted to the registry on 27 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects	689	679

Primary outcome: Percentage of Participants Who Appropriately Followed the Label Instructions

Time frame: 8 weeks. Number. Unit: Percentage of participants

Measure	Tamsulosin Hydrochloride n = 321
Value	85.4

Population analysed: Full Analysis Set for Actual Use Study (FAS-AUS), all subjects who self-selected to use the product, purchased the product, took at least one dose of the product and participated in at least one phone interview.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EVAL-SS	10 of 679 (1.5%)	26 of 679 (3.8%)	Not reported
Treated Set	10 of 351 (2.8%)	26 of 351 (7.4%)	Not reported
FAS-AUS	9 of 321 (2.8%)	22 of 321 (6.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30607798Roehrborn CG, Lowe FC, Gittelman M, Wruck JM, Verbeek AE. Management of Male Lower Urinary Tract Symptoms in a Simulated, Over-the-Counter Setting: An Exploratory Study of Tamsulosin. Drugs Aging. 2019 Feb;36(2):179-188. doi: 10.1007/s40266-018-0621-8.
Related InfoLink provided by the sponsor.

Related trials for Lower Urinary Tract Symptoms

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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tamsulosin in people with Lower Urinary Tract Symptoms, run by Boehringer Ingelheim at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Appropriately Followed the Label Instructions (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01726270, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.