Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116571
Status:
TERMINATED
Last Update Posted:
2006-10-03
First Post:
2005-06-29
Brief Title:
Photodynamic Therapy PDT for Lower Urinary Tract Symptoms PLUS
Sponsor:
QLT Inc
Organization:
QLT Inc
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None