The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months - Full Text View

Purpose

A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Drug: Silodosin	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multi-Center, Open-Label Evaluation of the Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia

Resource links provided by NLM:

MedlinePlus related topics: Enlarged Prostate (BPH)

Drug Information available for: Silodosin

U.S. FDA Resources

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:

Adverse Events [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.

Secondary Outcome Measures:

International Prostate Symptom Score (IPSS) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
The IPSS is a symptom severity scale from 0 to 35 that is derived from a 7 item questionnaire. 0 indicates no symptoms and 35 indicates most severe symptoms.


Enrollment:	661
Study Start Date:	September 2005
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Silodosin Silodosin 8 mg per day with food	Drug: Silodosin 8 mg daily Other Name: Rapaflo

Detailed Description:

This will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, and compliance.

All subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)

Eligibility


Ages Eligible for Study:	50 Years and older (Adult, Senior)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males in good general health and at least 50 years of age, who have completed SI04009 or SI04010.

Exclusion Criteria:

Medical conditions that would confound the efficacy evaluation.
Medical conditions in which it would be unsafe to use an alpha-blocker.
The use of concomitant drugs that would confound the efficacy evaluation.
The use of concomitant drugs that would be unsafe with this alpha-blocker.

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224133

Show 79 Study Locations

Sponsors and Collaborators

Watson Pharmaceuticals

Investigators


Study Director:	Lawrence Hill, Pharm D, RPh	Watson Pharmaceuticals

More Information

Additional Information:

FDA approval summary and product label This link exits the ClinicalTrials.gov site

Publications:

Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Silodosin in the treatment of the signs and symptoms of benign prostatic hyperplasia: a 9-month, open-label extension study. Urology. 2009 Dec;74(6):1318-22. doi: 10.1016/j.urology.2009.06.072. Epub 2009 Oct 7.


Responsible Party:	Gary Hoel, RPh, PhD, Executive Director of Clinical Research, Watson Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00224133 History of Changes
Other Study ID Numbers:	SI04011
Study First Received:	September 14, 2005
Results First Received:	December 23, 2009
Last Updated:	April 6, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:


benign prostatic hyperplasia, alpha blocker

Additional relevant MeSH terms:


Hyperplasia Prostatic Hyperplasia Pathologic Processes Prostatic Diseases Genital Diseases, Male 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

ClinicalTrials.gov processed this record on September 28, 2016