Benign Prostatic Hyperplasia Clinical Trial
Official title:
Phase 3 Multicenter Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX-1207 for the Treatment of BPH: Two Doses 1-7 Years Apart
| 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 is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.
| Status | Completed |
| Enrollment | 192 |
| Est. completion date | January 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 45 Years and older |
| Eligibility |
Inclusion Criteria: - Be male aged 45 or older. - Sign an informed consent form. - Be in good health. - Received NX-1207 in a previous completed study or received NX-1207 or placebo in a concurrent U.S. study (NX02-0017 and NX02-0018) and completed their V10 (365 day) visit. - Have Prostate Gland Volume = 25 mL (25 g). Exclusion Criteria: - Surgery or minimally invasive surgical therapy (MIST) for treatment of BPH after first NX-1207 injection - Post-void residual urine volume > 200 mL - Presence of a symptomatic median lobe of the prostate - History of use of self-catheterization for urinary retention. - Urinary retention in the previous 12 months. - Prostatitis - Urinary tract infection more than once in the past 12 months - Prostate or bladder cancer. - PSA =10 ng/mL - Poorly controlled diabetes - History or evidence of illness or condition that may interfere with study or endanger subject - Participation in a study of any investigational drug (other than NX-1207) or investigational device within the previous 90 days - Use of specific prescribed medications that may interfere with study or endanger subject |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| 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. | 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 | Bismarck | North Dakota |
| 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 | Concord | North Carolina |
| 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. | Houston | Texas |
| 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. | 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. | 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. | Missoula | Montana |
| 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. | New York | New York |
| 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. | Poughkeepsie | New York |
| 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 | Sarasota | Florida |
| 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 | Southaven | Mississippi |
| United States | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Tarzana | California |
| Lead Sponsor | Collaborator |
|---|---|
| Nymox Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety | Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG). | 180 days | Yes |
| Secondary | Symptomatic Improvement | Symptomatic improvement as measured by the change in American Urological Association (AUA) Symptom Index from baseline at 90 days. The AUA Symptom Index is a standardized questionnaire that uses seven questions relating to associated BPH symptoms to provide an assessment of symptom severity on a scale from 0 (no symptoms) to 35 (most severe). | 90 days | No |
| Secondary | Prostate Volume Change | Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography | 90 days | No |
| Secondary | Change in Urinary Peak Flow | Change in Urinary Peak Flow (Qmax) from baseline to 90 days as determined by urinary flow-rate recording (uroflowmetry). | 90 days | No |
| Secondary | Symptomatic Improvement | Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days. | 180 days | No |
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