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Sponsored by: |
QLT Inc |
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Information provided by: | QLT Inc |
ClinicalTrials.gov Identifier: | NCT00116571 |
The purpose of this study is to determine if transurethral photodynamic therapy with lemuteporfin has a therapeutic effect on lower urinary tract symptoms due to an enlarged prostate.
Photodynamic therapy (known as "PDT") is a treatment that uses light to make a drug work. This means the drug is "light-activated". Light-activated drugs do not work until a certain color of light shines on the drug. When the drug and the light combine, they react together to destroy tissue.
This study is investigating PDT with lemuteporfin as a possible treatment for an enlarged prostate. PDT with lemuteporfin may destroy overgrown prostate tissue and help urinary symptoms go back to normal.
Condition | Intervention | Phase |
---|---|---|
Prostatic Hyperplasia |
Drug: Lemuteporfin for injection Device: Transurethral drug delivery system Device: Transurethral light delivery system |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Randomized, Sham-Controlled, Double-Blind, Dose-Finding Study to Assess the Efficacy and Safety of Transurethral Photodynamic Therapy With Lemuteporfin in Subjects With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia |
Estimated Enrollment: | 180 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | December 2006 |
This is a multi-center, randomized, sham-controlled, double-blind, dose-finding study in parallel groups of subjects with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). All subjects will receive a fixed dose of lemuteporfin injected transurethrally into the prostate followed by transurethral application of either one of three active light doses or a sham light dose. Subjects will be followed for safety and efficacy for a minimum of three months to a maximum of 12 months. The primary study endpoint will be the change from baseline in AUA SI score at three months.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
San Bernardino Urological Associates | |
San Bernardino, California, United States, 92404 | |
United States, Louisiana | |
Regional Urology, LLC | |
Shreveport, Louisiana, United States, 71106 | |
United States, Maryland | |
Drs Werner, Murdock & Francis PA Urology Associates | |
Greenbelt, Maryland, United States, 20770 | |
United States, New Jersey | |
Lawrenceville Urology | |
Lawrenceville, New Jersey, United States, 08648 | |
United States, New York | |
AccuMed Research Associates | |
Garden City, New York, United States, 11530 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Texas | |
Urology San Antonio Research, PA | |
San Antonio, Texas, United States, 78229 | |
United States, Virginia | |
Devine Tidewater Urology | |
Virginia Beach, Virginia, United States, 23455 | |
Canada, British Columbia | |
Can-Med Clinical Research Inc | |
Victoria, British Columbia, Canada, V8T 5G1 |
Study Director: | Graeme Boniface, PhD | QLT Inc |
Study ID Numbers: | BPH 003 |
Study First Received: | June 29, 2005 |
Last Updated: | October 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00116571 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Benign Prostatic Hyperplasia (BPH) Photodynamic Therapy (PDT) Lower Urinary Tract Symptoms (LUTS) |
Signs and Symptoms Hyperplasia Prostatic Diseases Prostatic Hyperplasia Genital Diseases, Male |
Pathologic Processes |