Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018
NCT ID: NCT00945490
Last Updated: 2017-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2009-05-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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NX-1207
NX-1207
Single intraprostatic injection of 2.5 mg NX-1207
Placebo
Placebo
Single intraprostatic injection of placebo
Interventions
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NX-1207
Single intraprostatic injection of 2.5 mg NX-1207
Placebo
Single intraprostatic injection of placebo
Eligibility Criteria
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Inclusion Criteria
2. AUASI ≥ 15
3. Prostate Volume ≥ 30 mL ≤ 70 mL
4. Qmax \< 15 mL/sec based on a minimum void of 125 mL
5. Agree not to use any other approved or experimental BPH or OAB medication anytime during the study
Exclusion Criteria
2. Use of prescribed medications that may interfere with study or endanger subject
3. Presence of a median lobe of the prostate
4. Previous surgery or MIST for treatment of BPH
5. Post-void residual urine volume \> 200 mL
6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL
7. Participation in a study of any investigational drug or device within the previous 90 days
8. Prostate cancer
45 Years
MALE
No
Sponsors
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Nymox Corporation
INDUSTRY
Responsible Party
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Locations
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For information concerning this clinical site, please contact Nymox at 800-936-9669.
Laguna Hills, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Tarzana, California, United States
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Torrance, California, United States
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Denver, Colorado, United States
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Englewood, Colorado, United States
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Aventura, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Sarasota, Florida, United States
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Meridian, Idaho, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Glen Burnie, Maryland, United States
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Towson, Maryland, United States
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Grand Rapids, Michigan, United States
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Sartell, Minnesota, United States
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Southaven, Mississippi, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Brick, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Garden City, New York, United States
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New York, New York, United States
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Bismarck, North Dakota, United States
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Oklahoma City, Oklahoma, United States
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Bryn Mawr, Pennsylvania, United States
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Sewickley, Pennsylvania, United States
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Memphis, Tennessee, United States
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Houston, Texas, United States
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McAllen, Texas, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
Countries
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Other Identifiers
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NX02-0018
Identifier Type: -
Identifier Source: org_study_id
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