Trial Outcomes & Findings for An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms (NCT NCT01726270)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

689 participants

Primary outcome timeframe

8 weeks

Results posted on

2020-03-27

Participant Flow

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).

Participant milestones

Participant milestones
Measure	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.
Part 1, Self-Selection Phase STARTED	689
Part 1, Self-Selection Phase COMPLETED	679
Part 1, Self-Selection Phase NOT COMPLETED	10
Eligibility for Part 2 STARTED	389
Eligibility for Part 2 COMPLETED	369
Eligibility for Part 2 NOT COMPLETED	20
Part 2, Actual-Use Phase STARTED	369
Part 2, Actual-Use Phase COMPLETED	330
Part 2, Actual-Use Phase NOT COMPLETED	39

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Part 1, Self-Selection Phase Withdrawal by Subject	10
Eligibility for Part 2 Eligible but did not enter Part 2	20
Part 2, Actual-Use Phase Withdrawal by Subject	21
Part 2, Actual-Use Phase Adverse Event	6
Part 2, Actual-Use Phase Lost to Follow-up	5
Part 2, Actual-Use Phase Other than reason specified above	7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=679 Participants 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.
Age, Continuous	65.7 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	679 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Tamsulosin Hydrochloride n=321 Participants Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.
Percentage of Participants Who Appropriately Followed the Label Instructions	85.4 Percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Subjects who completed all three telephone follow-up interviews out of the FAS population

Percentage of participants who took no more than one capsule per day

Outcome measures

Outcome measures
Measure	Tamsulosin Hydrochloride n=300 Participants Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.
Percentage of Participants Who Took no More Than One Capsule Per Day	93.7 Percentage of participants Interval 90.3 to 96.1

SECONDARY outcome

Timeframe: 8 weeks

Population: 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

"Use-day" was defind as a calendar day for which data were available regarding use or non-use.

Outcome measures

Outcome measures
Measure	Tamsulosin Hydrochloride n=321 Participants Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.
Percentage of "Use-Days" for All Participants Who Took no More Than One Capsule Per Day	94.1 Percentage of participants Interval 90.9 to 96.2

SECONDARY outcome

Timeframe: 8 weeks

Population: 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

Includes participants who: 1. were less than 45 years of age at enrollment, and 2. spoke to a doctor during the actual use phase.

Outcome measures

Outcome measures
Measure	Tamsulosin Hydrochloride n=23 Participants Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.
Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase	30.4 Percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Evaluable Analysis Set for Self-Selection (EVAL-SS), all subjects who answered the self-selection question, probing question and followup questions.

Percentage of participants who are potentially at risk of harm by incorrectly selecting to use the study product out of the total study population

Outcome measures

Outcome measures
Measure	Tamsulosin Hydrochloride n=679 Participants Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 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	20.9 Percentage of participants Interval 17.9 to 24.2

SECONDARY outcome

Timeframe: 8 weeks

Population: Evaluable Analysis Set for Self-Selection (EVAL-SS), all subjects who answered the self-selection question, probing question and followup questions.

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.

Outcome measures

Outcome measures
Measure	Tamsulosin Hydrochloride n=679 Participants Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.
Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population	73.9 Percentage of participants Interval 70.5 to 77.2

Adverse Events

EVAL-SS

Serious events: 10 serious events

Other events: 26 other events

Deaths: 0 deaths

Treated Set

Serious events: 10 serious events

Other events: 26 other events

Deaths: 0 deaths

FAS-AUS

Serious events: 9 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EVAL-SS n=679 participants at risk 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).	Treated Set n=351 participants at risk 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).	FAS-AUS n=321 participants at risk 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).
Infections and infestations Abscess	0.15% 1/679 • 8 weeks Treated set	0.28% 1/351 • 8 weeks Treated set	0.31% 1/321 • 8 weeks Treated set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.15% 1/679 • 8 weeks Treated set	0.28% 1/351 • 8 weeks Treated set	0.31% 1/321 • 8 weeks Treated set
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.15% 1/679 • 8 weeks Treated set	0.28% 1/351 • 8 weeks Treated set	0.31% 1/321 • 8 weeks Treated set
Nervous system disorders Transient ischaemic attack	0.15% 1/679 • 8 weeks Treated set	0.28% 1/351 • 8 weeks Treated set	0.31% 1/321 • 8 weeks Treated set
Cardiac disorders Angina pectoris	0.15% 1/679 • 8 weeks Treated set	0.28% 1/351 • 8 weeks Treated set	0.00% 0/321 • 8 weeks Treated set
Cardiac disorders Atrial flutter	0.15% 1/679 • 8 weeks Treated set	0.28% 1/351 • 8 weeks Treated set	0.31% 1/321 • 8 weeks Treated set
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.15% 1/679 • 8 weeks Treated set	0.28% 1/351 • 8 weeks Treated set	0.31% 1/321 • 8 weeks Treated set
Gastrointestinal disorders Pancreatitis	0.15% 1/679 • 8 weeks Treated set	0.28% 1/351 • 8 weeks Treated set	0.31% 1/321 • 8 weeks Treated set
Musculoskeletal and connective tissue disorders Osteoarthritis	0.15% 1/679 • 8 weeks Treated set	0.28% 1/351 • 8 weeks Treated set	0.31% 1/321 • 8 weeks Treated set
General disorders Chest pain	0.15% 1/679 • 8 weeks Treated set	0.28% 1/351 • 8 weeks Treated set	0.31% 1/321 • 8 weeks Treated set

Other adverse events

Other adverse events
Measure	EVAL-SS n=679 participants at risk 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).	Treated Set n=351 participants at risk 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).	FAS-AUS n=321 participants at risk 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).
Infections and infestations Nasopharyngitis	3.8% 26/679 • 8 weeks Treated set	7.4% 26/351 • 8 weeks Treated set	6.9% 22/321 • 8 weeks Treated set

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
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Restriction type: OTHER