Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: Silodosin Drug: Tamsulosin Drug: Placebo Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : May 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Silodosin Drug: Silodosin
8 mg daily for 12 weeks
Other Name: KMD3213

Active Comparator: Tamsulosin Drug: Tamsulosin
0.4 mg daily for 12 weeks
Other Name: Omnic

Placebo Comparator: Placebo Drug: Placebo
once daily for 12 weeks




Primary Outcome Measures :
  1. Change in baseline total score on the International Prostate Symptom Score [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change in baseline obstructive subscore of the International Prostate Symptom Score; [ Time Frame: 12 weeks ]
  2. change in baseline irritative subscore of the International Prostate Symptom Score; [ Time Frame: 12 weeks ]
  3. change in baseline maximum urine flow rate; [ Time Frame: 12 weeks ]
  4. safety [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359905


Locations
Layout table for location information
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
RECORDATI GROUP
Investigators
Layout table for investigator information
Principal Investigator: Christopher Re Chapple, BSc MD Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Senior Clinical Project Leader, Recordati Industria Chimica e Farmaceutica S.p.A.
ClinicalTrials.gov Identifier: NCT00359905    
Other Study ID Numbers: KMD3213-IT-CL 0215
First Posted: August 3, 2006    Key Record Dates
Last Update Posted: February 19, 2009
Last Verified: February 2009
Keywords provided by RECORDATI GROUP:
Benign prostatic hyperplasia
alpha-blockers
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Tamsulosin
Silodosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents