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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00077012 |
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Date of registration:
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09/02/2004 |
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Primary sponsor: |
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Public title:
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Dose Escalation Study With QLT0074 for Benign Prostatic Hyperplasia
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Scientific title:
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A Phase I/II Dose Escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Transurethral Photodynamic Therapy With QLT0074 for Benign Prostatic Hyperplasia |
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Date of first enrolment:
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March 2003 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00077012 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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United States
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Key inclusion & exclusion criteria
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- Twenty-seven men with symptomatic BPH despite adequate drug therapy and who are
candidates for surgical or minimally invasive treatment will be enrolled in the
study.
- Subjects must have an AUA SI >13, Qmax between 5 and 15 mL/sec, and a urethral
treatment length between 30 and 65 mm (defined as the length of the urethra between
the bladder neck and the edge of the verumontanum distal to the bladder).
Age minimum:
N/A
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Benign Prostatic Hyperplasia
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Intervention(s)
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Drug: Photodynamic therapy
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Drug: QLT0074
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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