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

This study has been completed.
Sponsor:
Information provided by:
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00224133
First received: September 14, 2005
Last updated: April 6, 2010
Last verified: April 2010
Results First Received: December 23, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Benign Prostatic Hyperplasia
Intervention: Drug: Silodosin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
8 mg Silodosin Per Day With Food No text entered.

Participant Flow:   Overall Study
    8 mg Silodosin Per Day With Food  
STARTED     661  
COMPLETED     435  
NOT COMPLETED     226  
Adverse Event                 93  
Protocol Violation                 6  
Withdrawal by Subject                 33  
Lack of Efficacy                 58  
Lost to Follow-up                 21  
Physician Decision                 1  
Not specified                 14  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
8 mg Silodosin Per Day With Food No text entered.

Baseline Measures
    8 mg Silodosin Per Day With Food  
Number of Participants  
[units: participants]
  661  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     356  
>=65 years     305  
Age  
[units: years]
Mean ± Standard Deviation
  65.0  ± 7.79  
Gender  
[units: participants]
 
Female     0  
Male     661  
Region of Enrollment  
[units: participants]
 
United States     661  



  Outcome Measures

1.  Primary:   Adverse Events   [ Time Frame: 9 months ]

2.  Secondary:   International Prostate Symptom Score (IPSS)   [ Time Frame: 9 months ]
Results not yet posted.   Anticipated Posting Date:   03/2010   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: gary.hoel@watson.com


Publications of Results:

Responsible Party: Gary Hoel, RPh, PhD, Executive Director of Clinical Research, Watson Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00224133     History of Changes
Other Study ID Numbers: SI04011
Study First Received: September 14, 2005
Results First Received: December 23, 2009
Last Updated: April 6, 2010
Health Authority: United States: Food and Drug Administration