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

Sponsor
RECORDATI GROUP (Industry)
Overall Status
Completed
CT.gov ID
NCT00359905
Collaborator
(none)
1,228
Enrollment
1
Location
3
Arms
20
Duration (Months)
61.3
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Design

Study Type:
Interventional
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 1, 2006
Actual Primary Completion Date :
May 1, 2007
Actual Study Completion Date :
Jan 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Silodosin

Drug: Silodosin
8 mg daily for 12 weeks
Other Names:
  • KMD3213

    		•
    Active Comparator: Tamsulosin

    Drug: Tamsulosin
    0.4 mg daily for 12 weeks
    Other Names:
  • Omnic

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    once daily for 12 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Change in baseline total score on the International Prostate Symptom Score [12 weeks]

    Secondary Outcome Measures

    1. Change in baseline obstructive subscore of the International Prostate Symptom Score; [12 weeks]

    2. change in baseline irritative subscore of the International Prostate Symptom Score; [12 weeks]

    3. change in baseline maximum urine flow rate; [12 weeks]

    4. safety [52 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital Sheffield United Kingdom S10 2JF

    Sponsors and Collaborators

    • RECORDATI GROUP

    Investigators

    • Principal Investigator: Christopher Re Chapple, BSc MD, Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00359905
    Other Study ID Numbers:
    • KMD3213-IT-CL 0215
    First Posted:
    Aug 3, 2006
    Last Update Posted:
    Feb 19, 2009
    Last Verified:
    Feb 1, 2009
    Keywords provided by , ,
    Benign prostatic hyperplasia
    alpha-blockers
    Additional relevant MeSH terms:
    Prostatic Hyperplasia
    Hyperplasia
    Tamsulosin
    Silodosin

    Study Results

    No Results Posted as of Feb 19, 2009