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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 8 mg Silodosin Per Day With Food
Hide 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
Arm/Group Title 8 mg Silodosin Per Day With Food
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 661
Hide 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
1.Primary Outcome
Title Adverse Events
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
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
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
8 mg Silodosin Per Day With Food
Affected / at Risk (%)
Total   --/--    
Hide 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
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Gary Hoel, RPh, PhD, Executive Director of Clinical Research
Organization: Watson Laboratories, Inc.
Phone: 801-588-6641
EMail: gary.hoel@watson.com
Layout table for additonal information
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