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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01726270
• Collaborator: (none)
• Enrollment: 689
• Locations: 18
• Arm: 1
• Duration (Months): 3.9
• Patients Per Site: 38.3
• Patients Per Site Per Month: 9.7

Study Details

Study Description

Brief Summary

Multicenter trial conducted in Pharmacy retail centers

Condition or Disease	Intervention/Treatment	Phase
Lower Urinary Tract Symptoms	Drug: tamsulosin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 689 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tamsulosin hydrochloride patients will take drug for 8 weeks in this exploratory study	Drug: tamsulosin; 0.4 mg

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Appropriately Followed the Label Instructions [8 weeks]

   Includes subjects who reported: No improvement in urinary symptoms and stopped taking product, Reported worsening of urinary symptoms and stopped taking the product, Reported a new urinary symptom and stopped taking the product, Reported no "Stop Use" condition and never took more than 1 capsule on any given day, Reported a "Stop Use" condition and contacted a provider.

Secondary Outcome Measures

1. Percentage of Participants Who Took no More Than One Capsule Per Day [8 weeks]

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

2. Percentage of "Use-Days" for All Participants Who Took no More Than One Capsule Per Day [8 weeks]

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

3. Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase [8 weeks]

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

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 [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

5. Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population [8 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion criteria:

1. Men 18 years of age and older.

2. Able to speak, read and understand English.

3. Willing to participate in the study and voluntarily sign an informed consent document.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boehringer Ingelheim Investigational Site	Hoover	Alabama	United States
2	Boehringer Ingelheim Investigational Site	Mesa	Arizona	United States
3	Boehringer Ingelheim Investigational Site	Encino	California	United States
4	Boehringer Ingelheim Investigational Site	Garden Grove	California	United States
5	Boehringer Ingelheim Investigational Site	La Habra	California	United States
6	Boehringer Ingelheim Investigational Site	Anoka	Minnesota	United States
7	Boehringer Ingelheim Investigational Site	Elk River	Minnesota	United States
8	Boehringer Ingelheim Investigational Site	Fridley	Minnesota	United States
9	Boehringer Ingelheim Investigational Site	Roseville	Minnesota	United States
10	Boehringer Ingelheim Investigational Site	Saint Francis	Minnesota	United States
11	Boehringer Ingelheim Investigational Site	Albuquerque	New Mexico	United States
12	Boehringer Ingelheim Investigational Site	Longview	Texas	United States
13	Boehringer Ingelheim Investigational Site	Tyler	Texas	United States
14	Boehringer Ingelheim Investigational Site	Bountiful	Utah	United States
15	Boehringer Ingelheim Investigational Site	Layton	Utah	United States
16	Boehringer Ingelheim Investigational Site	Salt Lake City	Utah	United States
17	Boehringer Ingelheim Investigational Site	Syracuse	Utah	United States
18	Boehringer Ingelheim Investigational Site	Richmond	Virginia	United States

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT01726270
• Other Study ID Numbers: 527.82
• First Posted: Nov 14, 2012
• Last Update Posted: Mar 27, 2020
• Last Verified: Mar 1, 2020

• Additional relevant MeSH terms: Lower Urinary Tract Symptoms; Tamsulosin

Study Results

Participant Flow

Recruitment Details	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).

Arm/Group Title	All Subjects
Arm/Group Description	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.
Period Title: Part 1, Self-Selection Phase
STARTED	689
COMPLETED	679
NOT COMPLETED	10
Period Title: Part 1, Self-Selection Phase
STARTED	389
COMPLETED	369
NOT COMPLETED	20
Period Title: Part 1, Self-Selection Phase
STARTED	369
COMPLETED	330
NOT COMPLETED	39

Baseline Characteristics

Arm/Group Title	All Subjects
Arm/Group Description	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.
Overall Participants	679
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.7 (13.2)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	679 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Appropriately Followed the Label Instructions
Description	Includes subjects who reported: No improvement in urinary symptoms and stopped taking product, Reported worsening of urinary symptoms and stopped taking the product, Reported a new urinary symptom and stopped taking the product, Reported no "Stop Use" condition and never took more than 1 capsule on any given day, Reported a "Stop Use" condition and contacted a provider.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tamsulosin Hydrochloride
Arm/Group Description	Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.
Measure Participants	321
Number [Percentage of participants]	85.4 12.6%

2. Secondary Outcome

Title	Percentage of Participants Who Took no More Than One Capsule Per Day
Description	Percentage of participants who took no more than one capsule per day
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tamsulosin Hydrochloride
Arm/Group Description	Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.
Measure Participants	300
Number (95% Confidence Interval) [Percentage of participants]	93.7 13.8%

3. Secondary Outcome

Title	Percentage of "Use-Days" for All Participants Who Took no More Than One Capsule Per Day
Description	"Use-day" was defind as a calendar day for which data were available regarding use or non-use.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tamsulosin Hydrochloride
Arm/Group Description	Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.
Measure Participants	321
Number (95% Confidence Interval) [Percentage of participants]	94.1 13.9%

4. Secondary Outcome

Title	Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase
Description	Includes participants who: were less than 45 years of age at enrollment, and spoke to a doctor during the actual use phase.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tamsulosin Hydrochloride
Arm/Group Description	Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.
Measure Participants	23
Number [Percentage of participants]	30.4 4.5%

5. Secondary Outcome

Title	Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tamsulosin Hydrochloride
Arm/Group Description	Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.
Measure Participants	679
Number (95% Confidence Interval) [Percentage of participants]	20.9 3.1%

6. Secondary Outcome

Title	Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tamsulosin Hydrochloride
Arm/Group Description	Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.
Measure Participants	679
Number (95% Confidence Interval) [Percentage of participants]	73.9 10.9%

Adverse Events

Time Frame	8 weeks
Adverse Event Reporting Description	Treated set
Arm/Group Title	EVAL-SS		Treated Set		FAS-AUS
Arm/Group Description	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 (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).		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).
All Cause Mortality
	EVAL-SS		Treated Set		FAS-AUS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	EVAL-SS		Treated Set		FAS-AUS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/679 (1.5%)		10/351 (2.8%)		9/321 (2.8%)
Cardiac disorders
Angina pectoris	1/679 (0.1%)		1/351 (0.3%)		0/321 (0%)
Atrial flutter	1/679 (0.1%)		1/351 (0.3%)		1/321 (0.3%)
Gastrointestinal disorders
Pancreatitis	1/679 (0.1%)		1/351 (0.3%)		1/321 (0.3%)
General disorders
Chest pain	1/679 (0.1%)		1/351 (0.3%)		1/321 (0.3%)
Infections and infestations
Abscess	1/679 (0.1%)		1/351 (0.3%)		1/321 (0.3%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	1/679 (0.1%)		1/351 (0.3%)		1/321 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/679 (0.1%)		1/351 (0.3%)		1/321 (0.3%)
Malignant melanoma	1/679 (0.1%)		1/351 (0.3%)		1/321 (0.3%)
Nervous system disorders
Transient ischaemic attack	1/679 (0.1%)		1/351 (0.3%)		1/321 (0.3%)
Respiratory, thoracic and mediastinal disorders
Pneumothorax	1/679 (0.1%)		1/351 (0.3%)		1/321 (0.3%)
Other (Not Including Serious) Adverse Events
	EVAL-SS		Treated Set		FAS-AUS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/679 (3.8%)		26/351 (7.4%)		22/321 (6.9%)
Infections and infestations
Nasopharyngitis	26/679 (3.8%)		26/351 (7.4%)		22/321 (6.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.