A New Drug for Benign Prostatic Hyperplasia Compared With Placebo - Full Text View

Purpose

A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Drug: silodosin Other: Placebo	Phase III

ChemIDplus related topics:

Silodosin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:

Change in baseline score on the International Prostate Symptom Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in baseline urine flow rate Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	461
Study Start Date:	May 2005
Study Completion Date:	August 2006

Arms	Assigned Interventions
1: Experimental Silodosin	Drug: silodosin 8 mg daily for 12 weeks
2: Placebo Comparator Placebo	Other: Placebo 1 capsule daily for 12 weeks

Detailed Description:

This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in 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, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders 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 BPH.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224107

Show 43 Study Locations

Sponsors and Collaborators

Watson Pharmaceuticals

Investigators


Study Director:	Lawrence Hill, PharmD, RPh	Watson Pharmaceuticals

More Information

Responsible Party:	Watson ( Gary Hoel PhD Executive Director )
Study ID Numbers:	SI04009
First Received:	September 14, 2005
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00224107
Health Authority:	United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:

Benign prostatic hyperplasia, alpha blocker

Study placed in the following topic categories:

Signs and Symptoms

Hyperplasia

Prostatic Diseases

Prostatic Hyperplasia

Genital Diseases, Male

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Watson Pharmaceuticals
Information provided by:	Watson Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00224107