Urological ManifestationsPhase 3NCT02573311
Actual Use Study of Tamsulosin in Men
A Phase 3 study testing tamsulosin hydrochloride in people with Urological Manifestations, run by Boehringer Ingelheim at 40 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urological Manifestations
- What is being tested?
- tamsulosin hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,117 participants
- Where
- 40 sitesUnited States
- Study dates
- 23 Sep 2015to 1 Aug 2016
- Phase
- Phase 3
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Duran Central Pharmacy
Albuquerque, New Mexico, 87104
Sam's Regent Pharmacy
Albuquerque, New Mexico, 87109
Goodrich Pharmacy
Andover, Minnesota, 55304
Parkway Discount Drugs
Birmingham, Alabama, 35215
Goodrich Pharmacy
Blaine, Minnesota, 55434
Mountain West Apothecary
Bountiful, Utah, 84010
Total Care Pharmacy
Burlington, North Carolina, 27215
Kroger Pharmacy #342
Cary, North Carolina, 27513
Med Center Compounding Pharmacy & Health Center
Cleveland, Tennessee, 37311
Sutton Family Pharmacy
Dalton, Georgia, 30721
Goodrich Pharmacy
Elk River, Minnesota, 55330
Huff's Drug Store
Ellijay, Georgia, 30540
The Medicine Shoppe and Elsberry Pharmacy
Elsberry, Missouri, 63343
Foothills Compounding Pharmacy
Enumclaw, Washington, 98022
Garden Drug
Fort Lauderdale, Florida, 33309
Wynn's Pharmacy Incorporated
Griffin, Georgia, 30224
Family Care Pharmacy
Highland, Illinois, 62249
T.B. Bond Pharmacy
Hillsboro, Texas, 76645
Homewood Pharmacy
Homewood, Alabama, 35209
Robert's Discount Pharmacy
Hoover, Alabama, 35226
Eagle Pharmacy
Houston, Texas, 77099
Albers' Specialty Pharmacy
Kansas City, Missouri, 64111
Maple Mountain Pharmacy
Mapleton, Utah, 84664
Pharmacy at the Pig
McCalla, Alabama, 35111
Texas Road Pharmacy
Monroe, New Jersey, 08831
Northfield Pharmacy
Northfield, Minnesota, 55057
The Medicine Shoppe
Ogden, Utah, 84401
Pill Box Pharmacy
Pembroke Pines, Florida, 33026
Pinson Discount Drugs
Pinson, Alabama, 35126
Parkview Compounding Pharmacy
Rancho Cucamonga, California, 91730
Apex Specialty Pharmacy
Riverside, Missouri, 64150
Stevenson Family Pharmacy
Saint Joseph, Missouri, 64504
Cub Pharmacy #1924
Saint Louis Park, Minnesota, 55426
Countryside Pharmacy
Savannah, Missouri, 64485
Kelley-Ross Compounding Pharmacy
Seattle, Washington, 98104
Rxtra Care
Seattle, Washington, 98115
Kusler's Compounding Pharmacy
Snohomish, Washington, 98290
Charleston Pharmacy, South Charleston
South Charleston, Ohio, 45368
ACACIA Apothecary and Wellness
Tucson, Arizona, 85704
Family Plaza Pharmacy
West Jordan, Utah, 84088
About this study
Official title: A 6-month OTC-simulated, Open Label, Uncontrolled Study of Tamsulosin 0.4 mg in Men
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.
- Conditions
- Urological Manifestations
- Being tested
- tamsulosin hydrochloride
- Medical subject headings
- Urological Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamsulosin hydrochlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| men | Experimental | Not described Receives: Drug: tamsulosin hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL Within the First 12 Weeks of Using Study Product and do Not Stop Use or Initiate Contact With Doctor Out of Total Population in Cohort 1
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the Drug Facts Label (DFL) within the first 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Measured: 12 weeks
Secondary outcomes (8)
Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL During the Study (24 Weeks) and do Not Stop Use or Initiate Contact With a Doctor Out of the Total Population in Cohort 1
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL during the study (i.e., 24 weeks) and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Measured: 24 weeks
Percentage of Men Who Report Condition Listed Under "Stop Use and Ask a Doctor if" Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 12 Weeks
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 12 weeks of using study product is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Measured: Week 12
Percentage of Men Who Report Condition Listed Under "Stop Use and Ask a Doctor if" Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 24 Weeks
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 24 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within 24 weeks of using study product is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Measured: Week 24
Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL Within the First 12 Weeks of Using Study Product Out of the Total Population in Cohort 1
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the DFL within the first 12 weeks of using the study product out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval
Measured: 12 weeks
Percentage of Men Who Report at Baseline a Symptom or Condition Under the "Ask A Doctor Before Use" Section of the DFL and Initiate Contact With a Doctor Out of the Total Population in Cohort 1
Percentage of men who reported at baseline a symptom or condition under the "Ask A Doctor Before Use" section of the DFL and initiated contact with a doctor out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Measured: 24 weeks
Percentage of Men Who Report at Baseline a Symptom or Condition Under the "Ask A Doctor Before Use" Section of the DFL and Initiate Contact With a Doctor Out of the Total Population of Cohort 1 Who Report a Symptom or Condition
Percentage of men who reported at baseline a symptom or condition under the "Ask A Doctor Before Use" section of the DFL and initiated contact with a doctor out of the total population of men in Cohort 1 who reported a symptom or condition is presented along with 95% exact two sided Clopper-Pearson confidence interval.
Measured: 24 weeks
Percentage of Men Who Seek the Advice of a Physician Within the First 12/24 Weeks of the Study Out of the Total Population in Cohort 1
Percentage of men who sought advice of a physician within the first 12/24 weeks of the study out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval
Measured: Week 12 and Week 24
Percentage of Men Who Took Two or More Capsules Per Day Within the First 12/24 Weeks of Using Study Product Out of the Total Population in Cohort 1
Percentage of men who took two or more capsules per day within the first 12/24 weeks of using study product out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval
Measured: Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study start23 Sep 2015
- Primary completion1 Aug 2016
- Study completion1 Aug 2016
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.
- Other trials for Urological ManifestationsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573311
- Sponsor's protocol ID
- 527.85
- Status last verified
- Apr 2020
- First submitted
- 1 Oct 2015
- Last updated
- 8 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-month OTC-simulated, Open Label, Uncontrolled Study of Tamsulosin 0.4 mg in Men
- ClinicalTrials.gov ID
- NCT02573311
- Acronym / sponsor ID
- 527.85
- Conditions
- Urological Manifestations
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,117 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2015 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Posted 8 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| men | Experimental | Drug: tamsulosin hydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| tamsulosin hydrochloride | Drug | men |
Primary outcome
Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL Within the First 12 Weeks of Using Study Product and do Not Stop Use or Initiate Contact With Doctor Out of Total Population in Cohort 1
Time frame: 12 weeks
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the Drug Facts Label (DFL) within the first 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population is presented along with 95% exact two sided Clopper-Pearson confidence interval.
8 secondary outcomes
Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL During the Study (24 Weeks) and do Not Stop Use or Initiate Contact With a Doctor Out of the Total Population in Cohort 1
Time frame: 24 weeks
Percentage of Men Who Report Condition Listed Under "Stop Use and Ask a Doctor if" Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 12 Weeks
Time frame: Week 12
Percentage of Men Who Report Condition Listed Under "Stop Use and Ask a Doctor if" Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 24 Weeks
Time frame: Week 24
Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL Within the First 12 Weeks of Using Study Product Out of the Total Population in Cohort 1
Time frame: 12 weeks
Percentage of Men Who Report at Baseline a Symptom or Condition Under the "Ask A Doctor Before Use" Section of the DFL and Initiate Contact With a Doctor Out of the Total Population in Cohort 1
Time frame: 24 weeks
Percentage of Men Who Report at Baseline a Symptom or Condition Under the "Ask A Doctor Before Use" Section of the DFL and Initiate Contact With a Doctor Out of the Total Population of Cohort 1 Who Report a Symptom or Condition
Time frame: 24 weeks
Percentage of Men Who Seek the Advice of a Physician Within the First 12/24 Weeks of the Study Out of the Total Population in Cohort 1
Time frame: Week 12 and Week 24
Percentage of Men Who Took Two or More Capsules Per Day Within the First 12/24 Weeks of Using Study Product Out of the Total Population in Cohort 1
Time frame: Week 12 and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tamsulosin hydrochloride in people with Urological Manifestations, run by Boehringer Ingelheim at 40 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 5 inclusion and 5 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 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 8 Apr 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 Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL Within the First 12 Weeks of Using Study Product and do Not Stop Use or Initiate Contact With Doctor Out of Total Population in Cohort 1 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2020.