Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)

Phase 1

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: PRX302; Drug: Placebo

• Registration Number: NCT01454349
• Lead Sponsor: Sophiris Bio Corp

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2011-10-14
• Study First Posted: 2011-10-19
• Primary Completion: 2013-03
• Status Verified: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-19
• Last Update Posted: 2013-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months
• Written informed consent prior to enrollment in the study
• IPSS ≥12
• Prostate volume of 30 - 100 mL as determined by TRUS
• Maximum urine flow (Qmax) of 4 - 15 mL/sec
• Refractory, intolerant or refused the use of alpha-blockers and/or 5 alpha-reductase inhibitors
• Unwilling or unable to undergo conventional surgical or available minimally invasive treatments
• Blood PSA values <10 ng/mL

Exclusion Criteria

• Inability to void at least 125 mL of urine
• PVR volume >200 mL
• Presence of or history of certain conditions that could interfere with study results or endanger subject
• Use of certain prescribed medications that could interfere with study results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRX302	PRX302	-
Inactive substance	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety	Month 3	Safety of PRX302
Tolerability	Month 3	Tolerability of PRX302

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	Day 1	Pharmacokinetics (PK) measurements of PRX302
Safety	Month 12	Safety of PRX302
Tolerability	Month 12	Tolerability of PRX302
Efficacy	Month 12	Efficacy of PRX302 assessed by IPSS

Trial Locations

Locations (15)

South Orange County Medical Research Center; 🇺🇸 Laguna Hills, California, United States

Atlantic Urology Medical Group; 🇺🇸 Long Beach, California, United States

California Professional Research; 🇺🇸 Newport Beach, California, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

South Florida Medical Research; 🇺🇸 Aventura, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

The Iowa Clinic; 🇺🇸 West Des Moines, Iowa, United States

Accumed Research Associates; 🇺🇸 Garden City, New York, United States

University Urology Associates; 🇺🇸 New York, New York, United States

Premier Medical Group of the Hudson Valley; 🇺🇸 Poughkeepsie, New York, United States

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