A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224120
• Other study ID #: SI04010
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: December 11, 2009
• Start date: May 2005
• Est. completion date: May 2006

Study information

• Verified date: December 2009
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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 Internation Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 462
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Silodosin
8 mg daily for 12 weeks

Other:
• Placebo
One capsule daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective alpha1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2009 Jun;181(6):2634-40. doi: 10.1016/j.juro.2009.02.034. Epub 2009 Apr 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks		Baseline and 12 weeks	No
Secondary	Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks		Baseline and 12 weeks	No