Benign Prostatic Hyperplasia (BPH) Clinical Trial
Official title:
Phase III Multicenter Prospective Randomized Parallel-Group Placebo-Controlled Double Blind Clinical Evaluation of NX-1207 for the Treatment of BPH NX02-0018
| Verified date | March 2017 |
| Source | Nymox Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) as compared to placebo.
| Status | Completed |
| Enrollment | 500 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 45 Years and older |
| Eligibility |
Inclusion Criteria: 1. Provide signed informed consent prior to enrolment in the study 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: 1. History of illness or condition that may interfere with study or endanger subject 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Albany | New York |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Albuquerque | New Mexico |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Annapolis | Maryland |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Aventura | Florida |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Baltimore | Maryland |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Bismarck | North Dakota |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Brick | New Jersey |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Bryn Mawr | Pennsylvania |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Denver | Colorado |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Englewood | Colorado |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Garden City | New York |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Glen Burnie | Maryland |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669 | Grand Rapids | Michigan |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Houston | Texas |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Laguna Hills | California |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Las Vegas | Nevada |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Las Vegas | Nevada |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | McAllen | Texas |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Memphis | Tennessee |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Meridian | Idaho |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | New York | New York |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Ocala | Florida |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Oklahoma City | Oklahoma |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Orlando | Florida |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Richmond | Virginia |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | San Antonio | Texas |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | San Diego | California |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | San Diego | California |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Sarasota | Florida |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Sartell | Minnesota |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Sewickley | Pennsylvania |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Southaven | Mississippi |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Tarzana | California |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Torrance | California |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Towson | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Nymox Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | American Urological Association Symptom Index (AUASI) | 365 days | ||
| Secondary | American Urological Association Symptom Index (AUASI) | 90 days | ||
| Secondary | American Urological Association Symptom Index (AUASI) | 180 days | ||
| Secondary | American Urological Association Symptom Index (AUASI) | 270 days | ||
| Secondary | Peak urine flow rate (Qmax) | 365 days | ||
| Secondary | Peak urine flow rate (Qmax) | 90 days | ||
| Secondary | Peak urine flow rate (Qmax) | 180 days |
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