Benign Prostatic Hyperplasia 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 NX02-0017
| Verified date | April 2014 |
| Source | Nymox Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| 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 | November 2013 |
| Est. primary completion date | November 2013 |
| 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. IPSS = 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Anaheim | California |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Arlington | Texas |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Atherton | California |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669 | Atlanta | Georgia |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669 | Bala Cynwyd | Pennsylvania |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Bethany | Oklahoma |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669 | Birmingham | Alabama |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Brooklyn | New York |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Carrollton | Texas |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Cincinnati | Ohio |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669 | Columbus | Ohio |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Concord | North Carolina |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Dallas | Texas |
| 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. | Garden City | New York |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Huntsville | Alabama |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Jeffersonville | Indiana |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Knoxville | Tennessee |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | La Mesa | California |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Lancaster | Pennsylvania |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Lawrenceville | New Jersey |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Little Rock | Arkansas |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Long Beach | California |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Los Alamitos | California |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Missoula | Montana |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Mt. Laurel | New Jersey |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Myrtle Beach | South Carolina |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Naples | Florida |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | New Britain | Connecticut |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Newburg | Indiana |
| 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. | Orlando | Florida |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Poughkeepsie | New York |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Raleigh | North Carolina |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Roswell | Georgia |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Salem | Oregon |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Salt Lake City | Utah |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Shreveport | Louisiana |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Tallahassee | Florida |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Tucson | Arizona |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Voorhees | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Nymox Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | International Prostate Symptom Score (IPSS) | 365 days | No | |
| Secondary | International Prostate Symptom Score (IPSS) | 90 days | No | |
| Secondary | International Prostate Symptom Score (IPSS) | 180 days | No | |
| Secondary | International Prostate Symptom Score (IPSS) | 270 days | No | |
| Secondary | Peak urine flow rate (Qmax) | 365 days | No | |
| Secondary | Peak urine flow rate (Qmax) | 90 days | No | |
| Secondary | Peak urine flow rate (Qmax) | 180 days | No |
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