Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
Sponsor
Nymox Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00918983
Collaborator
(none)
500
41
2
55
12.2
0.2
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Study Start Date
:
Apr 1, 2009
Actual Primary Completion Date
:
Nov 1, 2013
Actual Study Completion Date
:
Nov 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NX-1207
|
Drug: NX-1207
Single intraprostatic injection of 2.5 mg NX-1207
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Single intraprostatic injection of placebo
|
Outcome Measures
Primary Outcome Measures
- International Prostate Symptom Score (IPSS) [365 days]
Secondary Outcome Measures
- International Prostate Symptom Score (IPSS) [90 days]
- International Prostate Symptom Score (IPSS) [180 days]
- International Prostate Symptom Score (IPSS) [270 days]
- Peak urine flow rate (Qmax) [365 days]
- Peak urine flow rate (Qmax) [90 days]
- Peak urine flow rate (Qmax) [180 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
45 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Provide signed informed consent prior to enrolment in the study
-
IPSS ≥ 15
-
Prostate Volume ≥ 30 mL ≤ 70 mL
-
Qmax < 15 mL/sec based on a minimum void of 125 mL
-
Agree not to use any other approved or experimental BPH or OAB medication anytime during the study
Exclusion Criteria:
-
History of illness or condition that may interfere with study or endanger subject
-
Use of prescribed medications that may interfere with study or endanger subject
-
Presence of a median lobe of the prostate
-
Previous surgery or MIST for treatment of BPH
-
Post-void residual urine volume > 200 mL
-
PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL
-
Participation in a study of any investigational drug or device within the previous 90 days
-
Prostate cancer
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For information concerning this clinical site, please contact Nymox at 800-936-9669 | Birmingham | Alabama | United States | 35209 |
| 2 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Huntsville | Alabama | United States | 35801 |
| 3 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Tucson | Arizona | United States | 85712 |
| 4 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Little Rock | Arkansas | United States | 72211 |
| 5 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Anaheim | California | United States | 92801 |
| 6 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Atherton | California | United States | 94027 |
| 7 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | La Mesa | California | United States | 91942 |
| 8 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Long Beach | California | United States | 90806 |
| 9 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Los Alamitos | California | United States | 90720 |
| 10 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Denver | Colorado | United States | 80211 |
| 11 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | New Britain | Connecticut | United States | 06052 |
| 12 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Naples | Florida | United States | 34102 |
| 13 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Ocala | Florida | United States | 34474 |
| 14 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Orlando | Florida | United States | 32806 |
| 15 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Tallahassee | Florida | United States | 32308 |
| 16 | For information concerning this clinical site, please contact Nymox at 800-936-9669 | Atlanta | Georgia | United States | 30308 |
| 17 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Roswell | Georgia | United States | 30076 |
| 18 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Jeffersonville | Indiana | United States | 47130 |
| 19 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Newburg | Indiana | United States | 47630 |
| 20 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Shreveport | Louisiana | United States | 71106 |
| 21 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Missoula | Montana | United States | 59802 |
| 22 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Lawrenceville | New Jersey | United States | 08648 |
| 23 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Mt. Laurel | New Jersey | United States | 08054 |
| 24 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Voorhees | New Jersey | United States | 08043 |
| 25 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Brooklyn | New York | United States | 11215 |
| 26 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Garden City | New York | United States | 11530 |
| 27 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Poughkeepsie | New York | United States | 12601 |
| 28 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Concord | North Carolina | United States | 28025 |
| 29 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Raleigh | North Carolina | United States | 27607 |
| 30 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Cincinnati | Ohio | United States | 45212 |
| 31 | For information concerning this clinical site, please contact Nymox at 800-936-9669 | Columbus | Ohio | United States | 43221 |
| 32 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Bethany | Oklahoma | United States | 73008 |
| 33 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Salem | Oregon | United States | 97301 |
| 34 | For information concerning this clinical site, please contact Nymox at 800-936-9669 | Bala Cynwyd | Pennsylvania | United States | 19004 |
| 35 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Lancaster | Pennsylvania | United States | 17604 |
| 36 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Myrtle Beach | South Carolina | United States | 29572 |
| 37 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Knoxville | Tennessee | United States | 37920 |
| 38 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Arlington | Texas | United States | 76017 |
| 39 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Carrollton | Texas | United States | 75010 |
| 40 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Dallas | Texas | United States | 75231 |
| 41 | For information concerning this clinical site, please contact Nymox at 800-936-9669. | Salt Lake City | Utah | United States | 84107 |
Sponsors and Collaborators
- Nymox Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Nymox Corporation
ClinicalTrials.gov Identifier:
NCT00918983
Other Study ID Numbers:
- NX02-0017
First Posted:
Jun 11, 2009
Last Update Posted:
Apr 30, 2014
Last Verified:
Apr 1, 2014
Keywords provided by Nymox Corporation
Additional relevant MeSH terms: