- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00945490
Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018
March 9, 2017 updated by: Nymox Corporation
Phase III Multicenter Prospective Randomized Parallel-Group Placebo-Controlled Double Blind Clinical Evaluation of NX-1207 for the Treatment of BPH NX02-0018
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Laguna Hills, California, United States, 92653
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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San Diego, California, United States, 92120
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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San Diego, California, United States, 92103
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Tarzana, California, United States, 91356
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Torrance, California, United States, 90505
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Colorado
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Denver, Colorado, United States, 80220
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Englewood, Colorado, United States, 80113
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Florida
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Aventura, Florida, United States, 33180
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Ocala, Florida, United States, 34474
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Orlando, Florida, United States, 32803
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Sarasota, Florida, United States, 34237
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Idaho
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Meridian, Idaho, United States, 83642
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Maryland
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Annapolis, Maryland, United States, 21401
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Baltimore, Maryland, United States, 21237
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Glen Burnie, Maryland, United States, 21061
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Towson, Maryland, United States, 21204
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Michigan
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Grand Rapids, Michigan, United States, 49546
- For information concerning this clinical site, please contact Nymox at 800-936-9669
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Minnesota
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Sartell, Minnesota, United States, 56377
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Mississippi
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Southaven, Mississippi, United States, 38671
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Nevada
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Las Vegas, Nevada, United States, 89148
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Las Vegas, Nevada, United States, 89146
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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New Jersey
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Brick, New Jersey, United States, 08724
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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New Mexico
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Albuquerque, New Mexico, United States, 87109
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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New York
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Albany, New York, United States, 12208
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Garden City, New York, United States, 11530
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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New York, New York, United States, 10016
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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North Dakota
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Bismarck, North Dakota, United States, 58501
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Pennsylvania
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Bryn Mawr, Pennsylvania, United States, 19010
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Sewickley, Pennsylvania, United States, 15143
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Tennessee
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Memphis, Tennessee, United States, 38119
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Texas
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Houston, Texas, United States, 77024
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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McAllen, Texas, United States, 78503
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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San Antonio, Texas, United States, 78229
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Virginia
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Richmond, Virginia, United States, 23235
- For information concerning this clinical site, please contact Nymox at 800-936-9669.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Single intraprostatic injection of placebo
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Experimental: NX-1207
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Single intraprostatic injection of 2.5 mg NX-1207
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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American Urological Association Symptom Index (AUASI)
Time Frame: 365 days
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365 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Peak urine flow rate (Qmax)
Time Frame: 365 days
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365 days
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Peak urine flow rate (Qmax)
Time Frame: 90 days
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90 days
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Peak urine flow rate (Qmax)
Time Frame: 180 days
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180 days
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American Urological Association Symptom Index (AUASI)
Time Frame: 90 days
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90 days
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American Urological Association Symptom Index (AUASI)
Time Frame: 180 days
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180 days
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American Urological Association Symptom Index (AUASI)
Time Frame: 270 days
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270 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
July 22, 2009
First Submitted That Met QC Criteria
July 22, 2009
First Posted (Estimate)
July 24, 2009
Study Record Updates
Last Update Posted (Actual)
March 10, 2017
Last Update Submitted That Met QC Criteria
March 9, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NX02-0018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Benign Prostatic Hyperplasia (BPH)
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Catholic University of the Sacred HeartCompletedBenign Prostatic Hyperplasia (BPH) | Benign Prostatic Enlargement (BPE)Italy
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Medi-Tate Ltd.CompletedBenign Prostatic Hyperplasia (BPH)Spain, Belgium, Italy, Switzerland, United Kingdom
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GemVax & KaelCompletedBenign Prostatic Hyperplasia (BPH)Korea, Republic of
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University of Kansas Medical CenterEnrolling by invitationBenign Prostatic Hyperplasia | BPHUnited States
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Brooklyn Urology Research GroupAmerican Medical Systems; Richard Wolf Medical Instruments Corporation (RWMIC)CompletedBenign Prostatic Hyperplasia (BPH)United States
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HistoSonics, Inc.WithdrawnBenign Prostatic Hyperplasia (BPH)
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Watson PharmaceuticalsCompletedBenign Prostatic Hyperplasia (BPH)United States
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Kissei Pharmaceutical Co., Ltd.Completed
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Lawson Health Research InstituteGyrus ACMI, Inc.CompletedBenign Prostatic Hyperplasia | BPHCanada
Clinical Trials on NX-1207
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-
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-
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-
Nymox CorporationCompletedPhase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)Benign Prostatic Hyperplasia (BPH) | Enlarged ProstateUnited States
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Jeil Pharmaceutical Co., Ltd.CompletedOveractive Bladder | Benign Prostatic Hyperplasia | LUTS
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Landos Biopharma Inc.RecruitingUlcerative ColitisUnited States, Belgium, Italy, Poland
-
Landos Biopharma Inc.CompletedUlcerative ColitisUnited States, Ukraine
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Lava TherapeuticsRecruitingMetastatic Castration Resistant Prostate CancerUnited States
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Abbisko Therapeutics Co, LtdRecruitingSolid TumorUnited States, China