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Dose Escalation Study With QLT0074 for Benign Prostatic Hyperplasia

NCT00077012 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2012-05-23

No results posted yet for this study

Summary

The primary objective of this study is to assess the safety and tolerance of transurethral photodynamic therapy (PDT) with QLT0074.

Secondary objectives are:

1. To determine if transurethral PDT with QLT0074 has a therapeutic effect on benign prostatic hyperplasia (BPH), evaluated by the American Urological Association Symptom Index (AUA SI), urinary flow rate (Qmax), and post-void residual volume (PVR).
2. To determine the extent of systemic exposure to QLT0074 following transurethral intraprostatic injection.
3. To select up to two transurethral PDT drug-light regimens for further clinical development.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DRUG

QLT0074

DRUG

Photodynamic therapy

Sponsors & Collaborators

  • QLT Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2005-05-31
Completion
2005-05-31

Countries

  • United States
  • Canada

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 NCT00077012 on ClinicalTrials.gov