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Study of Light-Activated Talaporfin Sodium in Patients With Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

NCT00918034 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2012-11-16

No results posted yet for this study

Summary

This is a phase 2 study to evaluate the safety and effectiveness of light-activated talaporfin sodium in patients with LUTS due to benign prostatic hyperplasia (BPH).

Conditions

  • Benign Prostatic Hyperplasia
  • Lower Urinary Tract Symptoms

Interventions

DRUG

talaporfin sodium

LS11 (talaporfin sodium) dose of 1mg/kg will be administered intravenously by slow push (3-5 minutes)

DEVICE

Transurethral illumination with light emitting diodes

A light dose of 100 Joules per centimeter (J/cm) will be delivered at 20 mW/cm to each patient for a treatment duration of 1 hour 23 minutes

PROCEDURE

Placement

Placement of device in prostate urethra

Sponsors & Collaborators

  • Light Sciences Oncology

    lead INDUSTRY

Principal Investigators

  • Sy-Shi Wang, PhD · Light Sciences Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • Australia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00918034 on ClinicalTrials.gov