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

Benign Prostatic Hyperplasia (BPH) 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: NCT00224107
• Other study ID #: SI04009
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: July 5, 2011
• Start date: May 2005
• Est. completion date: August 2006

Study information

• Verified date: July 2011
• 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 International Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 461
• Est. completion date: August 2006
• Est. primary completion date: August 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 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.

• 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 (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Silodosin
8 mg daily for 12 weeks

Other:
• Placebo
1 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Prostate Symptom Score (IPSS)	Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms	12 weeks	No
Secondary	Maximum Urine Flow Rate (Qmax)	Change from baseline in maximum urine flow rate (Qmax)at Week 12	12 weeks	No