A Phase 2 interventional study of tamsulosin in Lower Urinary Tract Symptoms, sponsored by Boehringer Ingelheim. Completed at 18 sites in United States. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-03-27.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
Multicenter trial conducted in Pharmacy retail centers
406 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.
This study's enrollment of 689 is above the median of 93 across 260 interventional studies indexed under Lower Urinary Tract Symptoms.
Browse Lower Urinary Tract Symptoms studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
patients will take drug for 8 weeks in this exploratory study
Drug: tamsulosin
0.4 mg
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.
Time frame: 8 weeks
Percentage of Participants Who Took no More Than One Capsule Per Day
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
"Use-day" was defind as a calendar day for which data were available regarding use or non-use.
Time frame: 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.
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
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
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.
Time frame: 8 weeks
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).
| Milestone | All Subjects |
|---|---|
| Started | 689 |
| Completed | 679 |
| Not completed | 10 |
| Withdrew: Withdrawal by subject | 10 |
| Milestone | All Subjects |
|---|---|
| Started | 389 |
| Completed | 369 |
| Not completed | 20 |
| Withdrew: Eligible but did not enter part 2 | 20 |
| Milestone | All Subjects |
|---|---|
| Started | 369 |
| Completed | 330 |
| Not completed | 39 |
| Withdrew: Withdrawal by subject | 21 |
| Withdrew: Adverse event | 6 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Other than reason specified above | 7 |
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.
| Percentage of participants | Tamsulosin Hydrochloride |
|---|---|
| Percentage of Participants Who Appropriately Followed the Label Instructions | 85.4 |
Percentage of participants who took no more than one capsule per day
| Percentage of participants | Tamsulosin Hydrochloride |
|---|---|
| Percentage of Participants Who Took no More Than One Capsule Per Day | 93.7 (90.3 to 96.1) |
"Use-day" was defind as a calendar day for which data were available regarding use or non-use.
| Percentage of participants | Tamsulosin Hydrochloride |
|---|---|
| Percentage of "Use-Days" for All Participants Who Took no More Than One Capsule Per Day | 94.1 (90.9 to 96.2) |
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 | Tamsulosin Hydrochloride |
|---|---|
| Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase | 30.4 |
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 | Tamsulosin Hydrochloride |
|---|---|
| Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population | 20.9 (17.9 to 24.2) |
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 | Tamsulosin Hydrochloride |
|---|---|
| Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population | 73.9 (70.5 to 77.2) |
Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EVAL-SS | — | 10/679 (1.5%) | 26/679 (3.8%) |
| Treated Set | — | 10/351 (2.8%) | 26/351 (7.4%) |
| FAS-AUS | — | 9/321 (2.8%) | 22/321 (6.9%) |
| Event | EVAL-SS | Treated Set | FAS-AUS |
|---|---|---|---|
| AbscessInfections and infestations | 1/679 | 1/351 | 1/321 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/679 | 1/351 | 1/321 |
| Malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/679 | 1/351 | 1/321 |
| Transient ischaemic attackNervous system disorders | 1/679 | 1/351 | 1/321 |
| Atrial flutterCardiac disorders | 1/679 | 1/351 | 1/321 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 1/679 | 1/351 | 1/321 |
| PancreatitisGastrointestinal disorders | 1/679 | 1/351 | 1/321 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 1/679 | 1/351 | 1/321 |
| Chest painGeneral disorders | 1/679 | 1/351 | 1/321 |
| Angina pectorisCardiac disorders | 1/679 | 1/351 | 0/321 |
| Event | EVAL-SS | Treated Set | FAS-AUS |
|---|---|---|---|
| NasopharyngitisInfections and infestations | 26/679 | 26/351 | 22/321 |
Evaluable Analysis Set for Self-Selection (Eval-SS): All subjects who answered self-selection question, probing question and follow-up questions
| Age, Continuous(years) | All Subjects |
|---|---|
| Mean | 65.7 ± 13.2 |
| Sex: Female, Male(Participants) | All Subjects |
|---|---|
| Female | 0 |
| Male | 679 |
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim