The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months

• ClinicalTrials.gov Identifier: NCT00224133
• Recruitment Status: Completed
• First Posted: September 22, 2005
• Results First Posted: April 27, 2010
• Last Update Posted: April 27, 2010
• Sponsor: Watson Pharmaceuticals
• Information provided by: Watson Pharmaceuticals

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Benign Prostatic Hyperplasia
• Intervention: Drug: Silodosin
• Enrollment: 661

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	8 mg Silodosin Per Day With Food
Arm/Group Description	[Not Specified]
Period Title: Overall Study
Started	661
Completed	435
Not Completed	226
Reason Not Completed
Adverse Event	93
Protocol Violation	6
Withdrawal by Subject	33
Lack of Efficacy	58
Lost to Follow-up	21
Physician Decision	1
Other	14

Baseline Characteristics

Arm/Group Title		8 mg Silodosin Per Day With Food
Arm/Group Description		[Not Specified]
Overall Number of Baseline Participants		661
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	661 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	356 53.9%
	>=65 years	305 46.1%
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	661 participants
		65.0 (7.79)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	661 participants
	Female	0 0.0%
	Male	661 100.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	661 participants
		661

Outcome Measures

1. Primary Outcome

Title	Adverse Events
Description	All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Safety population was analyzed. This population is defined as all enrolled patients who received at least one dose of study drug.

Arm/Group Title	8 mg Silodosin Per Day With Food
Arm/Group Description:	[Not Specified]
Overall Number of Participants Analyzed	661
Measure Type: Number; Unit of Measure: participants
Patients with at least 1 adverse event	431
Patients with drug related adverse event	188
Patients with a serious adverse events	29
Patients with a drug related serious adverse event	0
Patients discontinued due to an adverse event	86
Discontinued for drug related adverse event	54

2. Secondary Outcome

Title	International Prostate Symptom Score (IPSS)
Description	The IPSS is a symptom severity scale from 0 to 35 that is derived from a 7 item questionnaire. 0 indicates no symptoms and 35 indicates most severe symptoms.
Time Frame	9 months

Outcome Measure Data Not Reported

Adverse Events

Time Frame	9 months
Adverse Event Reporting Description	No subject experienced a serious adverse event that was related to treatment.
Arm/Group Title	8 mg Silodosin Per Day With Food
Arm/Group Description	[Not Specified]
All-Cause Mortality
	8 mg Silodosin Per Day With Food
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	8 mg Silodosin Per Day With Food
	Affected / at Risk (%)	# Events
Total	29/661 (4.39%)
Cardiac disorders
Acute myocardial infarction * 1	1/661 (0.15%)	1
Arrythmia * 1	1/661 (0.15%)	1
Atrial fibrillation * 1	2/661 (0.30%)	2
Myocardial infarction * 1	1/661 (0.15%)	1
Gastrointestinal disorders
Gastritis * 1	1/661 (0.15%)	1
Infections and infestations
Diverticulitis * 1	2/661 (0.30%)	2
Lobar pneumonia * 1	1/661 (0.15%)	1
Injury, poisoning and procedural complications
Back injury * 1	1/661 (0.15%)	1
Concussion * 1	1/661 (0.15%)	1
Musculoskeletal and connective tissue disorders
Arthralgia * 1	1/661 (0.15%)	1
Osteoarthritis * 1	4/661 (0.61%)	4
Pain in extremity * 1	1/661 (0.15%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant * 1	3/661 (0.45%)	3
Prostate cancer * 1	2/661 (0.30%)	2
Squamous cell carcinoma * 1	1/661 (0.15%)	1
Nervous system disorders
Carotid artery stenosis * 1	1/661 (0.15%)	1
Nerve root lesion * 1	1/661 (0.15%)	1
Transient ischemic attack * 1	1/661 (0.15%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism * 1	2/661 (0.30%)	2
Surgical and medical procedures
Hip arthroplasty * 1	2/661 (0.30%)	2
Knee arthroplasty * 1	1/661 (0.15%)	1
Spinal laminectomy * 1	1/661 (0.15%)	1
Vascular disorders
Aneurysm * 1	1/661 (0.15%)	1
Deep vein thrombosis * 1	1/661 (0.15%)	1
Femoral artery occlusion * 1	1/661 (0.15%)	1
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	8 mg Silodosin Per Day With Food
	Affected / at Risk (%)	# Events
Total	138/661 (20.88%)
Reproductive system and breast disorders
Retrograde ejaculation * 1	138/661 (20.88%)	139
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Gary Hoel, RPh, PhD, Executive Director of Clinical Research
• Organization: Watson Laboratories, Inc.
• Phone: 801-588-6641
• EMail: gary.hoel@watson.com

Publications of Results:

Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Silodosin in the treatment of the signs and symptoms of benign prostatic hyperplasia: a 9-month, open-label extension study. Urology. 2009 Dec;74(6):1318-22. doi: 10.1016/j.urology.2009.06.072. Epub 2009 Oct 7.

• Responsible Party: Gary Hoel, RPh, PhD, Executive Director of Clinical Research, Watson Laboratories, Inc.
• ClinicalTrials.gov Identifier: NCT00224133
• Other Study ID Numbers: SI04011
• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Results First Submitted: December 23, 2009
• Results First Posted: April 27, 2010
• Last Update Posted: April 27, 2010