Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018
Phase III Multicenter Prospective Randomized Parallel-Group Placebo-Controlled Double Blind Clinical Evaluation of NX-1207 for the Treatment of BPH NX02-0018
1 other identifier
interventional
500
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2009
Longer than P75 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 22, 2009
CompletedFirst Posted
Study publicly available on registry
July 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMarch 10, 2017
March 1, 2017
5 years
July 22, 2009
March 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
American Urological Association Symptom Index (AUASI)
365 days
Secondary Outcomes (6)
American Urological Association Symptom Index (AUASI)
90 days
American Urological Association Symptom Index (AUASI)
180 days
American Urological Association Symptom Index (AUASI)
270 days
Peak urine flow rate (Qmax)
365 days
Peak urine flow rate (Qmax)
90 days
- +1 more secondary outcomes
Study Arms (2)
NX-1207
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Laguna Hills, California, 92653, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
San Diego, California, 92103, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
San Diego, California, 92120, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Tarzana, California, 91356, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Torrance, California, 90505, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Denver, Colorado, 80220, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Englewood, Colorado, 80113, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Aventura, Florida, 33180, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Ocala, Florida, 34474, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Orlando, Florida, 32803, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Sarasota, Florida, 34237, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Meridian, Idaho, 83642, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Annapolis, Maryland, 21401, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Baltimore, Maryland, 21237, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Glen Burnie, Maryland, 21061, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Towson, Maryland, 21204, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669
Grand Rapids, Michigan, 49546, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Sartell, Minnesota, 56377, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Southaven, Mississippi, 38671, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Las Vegas, Nevada, 89146, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Las Vegas, Nevada, 89148, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Brick, New Jersey, 08724, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Albuquerque, New Mexico, 87109, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Albany, New York, 12208, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Garden City, New York, 11530, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
New York, New York, 10016, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Bismarck, North Dakota, 58501, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Oklahoma City, Oklahoma, 73104, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Bryn Mawr, Pennsylvania, 19010, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Sewickley, Pennsylvania, 15143, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Memphis, Tennessee, 38119, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Houston, Texas, 77024, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
McAllen, Texas, 78503, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
San Antonio, Texas, 78229, United States
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Richmond, Virginia, 23235, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2009
First Posted
July 24, 2009
Study Start
May 1, 2009
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
March 10, 2017
Record last verified: 2017-03