Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018
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| ClinicalTrials.gov Identifier: NCT00945490 |
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Recruitment Status :
Completed
First Posted : July 24, 2009
Last Update Posted : March 10, 2017
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Sponsor:
Nymox Corporation
Information provided by (Responsible Party):
Nymox Corporation
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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 |
|---|---|---|
| Benign Prostatic Hyperplasia (BPH) | Drug: NX-1207 Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 500 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| 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 NX02-0018 |
| Study Start Date : | May 2009 |
| Actual Primary Completion Date : | May 2014 |
| Actual Study Completion Date : | May 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Enlarged Prostate (BPH)
| 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 |
Primary Outcome Measures :
- American Urological Association Symptom Index (AUASI) [ Time Frame: 365 days ]
Secondary Outcome Measures :
- American Urological Association Symptom Index (AUASI) [ Time Frame: 90 days ]
- American Urological Association Symptom Index (AUASI) [ Time Frame: 180 days ]
- American Urological Association Symptom Index (AUASI) [ Time Frame: 270 days ]
- Peak urine flow rate (Qmax) [ Time Frame: 365 days ]
- Peak urine flow rate (Qmax) [ Time Frame: 90 days ]
- Peak urine flow rate (Qmax) [ Time Frame: 180 days ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provide signed informed consent prior to enrolment in the study
- AUASI ≥ 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945490
Locations
| United States, California | |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | |
| Laguna Hills, California, United States, 92653 | |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | |
| San Diego, California, United States, 92103 | |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | |
| San Diego, California, United States, 92120 | |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | |
| Tarzana, California, United States, 91356 | |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | |
| Torrance, California, United States, 90505 | |
| United States, Colorado | |
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| Denver, Colorado, United States, 80220 | |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | |
| Englewood, Colorado, United States, 80113 | |
| United States, Florida | |
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| Aventura, Florida, United States, 33180 | |
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| Ocala, Florida, United States, 34474 | |
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| Orlando, Florida, United States, 32803 | |
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| Sarasota, Florida, United States, 34237 | |
| United States, Idaho | |
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| Meridian, Idaho, United States, 83642 | |
| United States, Maryland | |
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| Annapolis, Maryland, United States, 21401 | |
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| Baltimore, Maryland, United States, 21237 | |
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| Glen Burnie, Maryland, United States, 21061 | |
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| Towson, Maryland, United States, 21204 | |
| United States, Michigan | |
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| Grand Rapids, Michigan, United States, 49546 | |
| United States, Minnesota | |
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| Sartell, Minnesota, United States, 56377 | |
| United States, Mississippi | |
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| Southaven, Mississippi, United States, 38671 | |
| United States, Nevada | |
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| Las Vegas, Nevada, United States, 89146 | |
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| Las Vegas, Nevada, United States, 89148 | |
| United States, New Jersey | |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | |
| Brick, New Jersey, United States, 08724 | |
| United States, New Mexico | |
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| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
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| Albany, New York, United States, 12208 | |
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| Garden City, New York, United States, 11530 | |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | |
| New York, New York, United States, 10016 | |
| United States, North Dakota | |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Oklahoma | |
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| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
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| Bryn Mawr, Pennsylvania, United States, 19010 | |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | |
| Sewickley, Pennsylvania, United States, 15143 | |
| United States, Tennessee | |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
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| Houston, Texas, United States, 77024 | |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | |
| McAllen, Texas, United States, 78503 | |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| For information concerning this clinical site, please contact Nymox at 800-936-9669. | |
| Richmond, Virginia, United States, 23235 | |
Sponsors and Collaborators
Nymox Corporation
| Responsible Party: | Nymox Corporation |
| ClinicalTrials.gov Identifier: | NCT00945490 |
| Other Study ID Numbers: |
NX02-0018 |
| First Posted: | July 24, 2009 Key Record Dates |
| Last Update Posted: | March 10, 2017 |
| Last Verified: | March 2017 |
Keywords provided by Nymox Corporation:
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Benign prostatic hyperplasia BPH Enlarged prostate |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Pathologic Processes Prostatic Diseases |
Genital Diseases, Male Genital Diseases Urogenital Diseases Male Urogenital Diseases |