Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH
Information source: Recordati Industria Chimica e Farmaceutica S.p.A.
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia
Intervention: silodosin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Recordati Industria Chimica e Farmaceutica S.p.A. Official(s) and/or principal investigator(s):
Christopher Re Chapple, BSc MD, Principal Investigator, Affiliation: Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital
Overall contact:
Massimo Casi, MD, Phone: +39 0248787, Ext: 456, Email: casi.m@recordati.it
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in baseline score on the International Prostate Symptom Score
Secondary outcome: 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
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
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Massimo Casi, MD, Phone: +39 0248787, Ext: 456, Email: casi.m@recordati.it
Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital, Sheffield S10 2JF, United Kingdom; Recruiting
Christopher Re Chapple, BSc MD, Phone: +44 07768902102, Email: c.r.chapple@sheffield.ac.uk
Susannah Hulton, RGN, Phone: +44 0114 2711870, Email: susannah.hulton@sth.nhs.uk
Christopher Re Chapple, Bsc MD, Principal Investigator
Additional Information
Starting date: May 2006
Ending date: February 2008
Last updated: August 2, 2006
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