Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH
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| ClinicalTrials.gov Identifier: NCT00359905 |
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Recruitment Status :
Completed
First Posted : August 3, 2006
Last Update Posted : February 19, 2009
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Sponsor:
RECORDATI GROUP
Information provided by:
RECORDATI GROUP
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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 |
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 : | 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
MedlinePlus related topics:
Enlarged Prostate (BPH)
| 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 :
- Change in baseline total score on the International Prostate Symptom Score [ Time Frame: 12 weeks ]
Secondary Outcome Measures :
- 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 ]
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| 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
| United Kingdom | |
| 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
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Benign prostatic hyperplasia alpha-blockers |
Additional relevant MeSH terms:
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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 |