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Multicenter trial conducted in Pharmacy retail centers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tamsulosin hydrochloride | Experimental | patients will take drug for 8 weeks in this exploratory study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tamsulosin | Drug | 0.4 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Appropriately Followed the Label Instructions | Includes subjects who reported:
| 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Took no More Than One Capsule Per Day | Percentage of participants who took no more than one capsule per day | 8 weeks |
| Percentage of "Use-Days" for All Participants Who Took no More Than One Capsule Per Day |
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Inclusion criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Hoover | Alabama | United States | |||
| Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30607798 | Derived | 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. |
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Study had 2 parts: In part 1 participants reviewed the product label and responded to a question about whether the product is appropriate for them to use (self-selection), selected participants then entered part 2 where they recieved study product (actual use).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | Part 1 included subjects who answer the self-selection question, probing question and follow-up questions. Part 2 included subjects who self-selected to use the product, purchase the product and took at least one dose of drug and participate in at least 1 phone interview. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1, Self-Selection Phase |
|
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"Use-day" was defind as a calendar day for which data were available regarding use or non-use.
| 8 weeks |
| Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase | Includes participants who:
| 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 | 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. | 8 weeks |
| Mesa |
| Arizona |
| United States |
| Boehringer Ingelheim Investigational Site | Encino | California | United States |
| Boehringer Ingelheim Investigational Site | Garden Grove | California | United States |
| Boehringer Ingelheim Investigational Site | La Habra | California | United States |
| Boehringer Ingelheim Investigational Site | Anoka | Minnesota | United States |
| Boehringer Ingelheim Investigational Site | Elk River | Minnesota | United States |
| Boehringer Ingelheim Investigational Site | Fridley | Minnesota | United States |
| Boehringer Ingelheim Investigational Site | Roseville | Minnesota | United States |
| Boehringer Ingelheim Investigational Site | Saint Francis | Minnesota | United States |
| Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | United States |
| Boehringer Ingelheim Investigational Site | Longview | Texas | United States |
| Boehringer Ingelheim Investigational Site | Tyler | Texas | United States |
| Boehringer Ingelheim Investigational Site | Bountiful | Utah | United States |
| Boehringer Ingelheim Investigational Site | Layton | Utah | United States |
| Boehringer Ingelheim Investigational Site | Salt Lake City | Utah | United States |
| Boehringer Ingelheim Investigational Site | Syracuse | Utah | United States |
| Boehringer Ingelheim Investigational Site | Richmond | Virginia | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Eligibility for Part 2 |
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| Part 2, Actual-Use Phase |
|
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Evaluable Analysis Set for Self-Selection (Eval-SS): All subjects who answered self-selection question, probing question and follow-up questions
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Part 1 included subjects who answer the self-selection question, probing question and follow-up questions. Part 2 included subjects who self-selected to use the product, purchase the product and took at least one dose of drug and participate in at least 1 phone interview. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Appropriately Followed the Label Instructions | Includes subjects who reported:
| 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. | Posted | Number | Percentage of participants | 8 weeks |
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| Secondary | Percentage of Participants Who Took no More Than One Capsule Per Day | Percentage of participants who took no more than one capsule per day | Subjects who completed all three telephone follow-up interviews out of the FAS population | Posted | Number | 95% Confidence Interval | Percentage of participants | 8 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | 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 | Posted | Number | 95% Confidence Interval | Percentage of participants | 8 weeks |
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| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase | Includes participants who:
| Full Analysis Set for Actual Use Study- Under 45 years (FAS-AUS45), all subjects less than 45 years of age 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 | Posted | Number | Percentage of participants | 8 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Evaluable Analysis Set for Self-Selection (EVAL-SS), all subjects who answered the self-selection question, probing question and followup questions. | Posted | Number | 95% Confidence Interval | Percentage of participants | 8 weeks |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | Evaluable Analysis Set for Self-Selection (EVAL-SS), all subjects who answered the self-selection question, probing question and followup questions. | Posted | Number | 95% Confidence Interval | Percentage of participants | 8 weeks |
|
|
8 weeks
Treated set
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EVAL-SS | Evaluable Analysis Set for Self-Selection (EVAL-SS): The EVAL-SS included all subjects who answered the self-selection question, probing question and follow-up questions (Part 1). | 10 | 679 | 26 | 679 | ||
| EG001 | Treated Set | Treated Set (TS): The TS included all subjects who self-selected to use the product, purchased the product, and then took at least one dose of drug (Part 2). | 10 | 351 | 26 | 351 | ||
| EG002 | FAS-AUS | Full Analysis Set for Actual Use Decision (FAS-AUS): The FAS-AUS included all subjects who self-selected to use the product, purchased the product, took at least one dose of drug and participated in at least 1 phone interview (Part 2). | 9 | 321 | 22 | 321 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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| Other than reason specified above |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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