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Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH

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: NCT00359905
Recruitment Status : Completed
First Posted : August 3, 2006
Last Update Posted : February 19, 2009
Sponsor:
Information provided by:
RECORDATI GROUP

Tracking Information
First Submitted Date  ICMJE August 2, 2006
First Posted Date  ICMJE August 3, 2006
Last Update Posted Date February 19, 2009
Study Start Date  ICMJE May 2006
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2009)
Change in baseline total score on the International Prostate Symptom Score [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2006)
Change in baseline score on the International Prostate Symptom Score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2009)
  • Change in baseline obstructive subscore of the International Prostate Symptom Score; [ Time Frame: 12 weeks ]
  • change in baseline irritative subscore of the International Prostate Symptom Score; [ Time Frame: 12 weeks ]
  • change in baseline maximum urine flow rate; [ Time Frame: 12 weeks ]
  • safety [ Time Frame: 52 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2006)
  • Change in baseline obstructive subscore of the International Prostate Symptom Score;
  • change in baseline irritative subscore of the International Prostate Symptom Score;
  • change in baseline maximum urine flow rate;
  • safety
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH
Official Title  ICMJE Evaluation of the Efficacy and Safety of Silodosin vs. Tamsulosin and Placebo in the Treatment of the Signs and Symptoms of BPH. Multicentre, Randomised, Double-Blind, Controlled Trial With an Optional Long-Term, Open-Label Extension Phase.
Brief Summary A new drug for the treatment of benign prostatic hyperplasia is compared with placebo and tamsulosin (a drug belonging to the same therapeutic class) for to determine if it is safe and effective (the first phase of the study lasts approximately 18 weeks) and then is used for another 9 months to determine its long-term safety.
Detailed Description This is a multi-centre, double-blind, placebo and active controlled, parallel 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia, followed by a 9 month open-label phase. The following procedures are used: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, quality of life and compliance. 93 centres in 11 European countries (Finland, France, Germany, Italy, Netherlands, Poland, Romania, Russia, Spain, Ukraine, UK) will be involved
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Benign Prostatic Hyperplasia
Intervention  ICMJE
  • Drug: Silodosin
    8 mg daily for 12 weeks
    Other Name: KMD3213
  • Drug: Tamsulosin
    0.4 mg daily for 12 weeks
    Other Name: Omnic
  • Drug: Placebo
    once daily for 12 weeks
Study Arms  ICMJE
  • Experimental: Silodosin
    Intervention: Drug: Silodosin
  • Active Comparator: Tamsulosin
    Intervention: Drug: Tamsulosin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2009)
1228
Original Enrollment  ICMJE
 (submitted: August 2, 2006)
1400
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males in good general health and at least 50 years of age, with symptoms of moderate to severe Benign Prostatic Hyperplasia

Exclusion Criteria:

  • Medical conditions that would confound the efficacy evaluation
  • Medical conditions in which it would be unsafe to use an alpha-blocker
  • Use of concomitant drugs that would confound the efficacy evaluation
  • Use of concomitant drugs that would be unsafe with this alpha-blocker
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00359905
Other Study ID Numbers  ICMJE KMD3213-IT-CL 0215
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Senior Clinical Project Leader, Recordati Industria Chimica e Farmaceutica S.p.A.
Study Sponsor  ICMJE RECORDATI GROUP
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Re Chapple, BSc MD Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital
PRS Account RECORDATI GROUP
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP