Benign Prostatic Hyperplasia (BPH)Phase 3NCT00945490
Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018
A Phase 3 study testing NX-1207 in people with Benign Prostatic Hyperplasia (BPH), run by Nymox Corporation at 35 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- NX-1207
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 35 sitesUnited States
- Study dates
- May 2009to May 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Albany, New York, 12208
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Albuquerque, New Mexico, 87109
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Annapolis, Maryland, 21401
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Aventura, Florida, 33180
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Baltimore, Maryland, 21237
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Bismarck, North Dakota, 58501
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Brick, New Jersey, 08724
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Bryn Mawr, Pennsylvania, 19010
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Denver, Colorado, 80220
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Englewood, Colorado, 80113
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Garden City, New York, 11530
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Glen Burnie, Maryland, 21061
For information concerning this clinical site, please contact Nymox at 800-936-9669
Grand Rapids, Michigan, 49546
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Houston, Texas, 77024
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Laguna Hills, California, 92653
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Las Vegas, Nevada, 89146
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Las Vegas, Nevada, 89148
For information concerning this clinical site, please contact Nymox at 800-936-9669.
McAllen, Texas, 78503
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Memphis, Tennessee, 38119
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Meridian, Idaho, 83642
For information concerning this clinical site, please contact Nymox at 800-936-9669.
New York, New York, 10016
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Ocala, Florida, 34474
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Oklahoma City, Oklahoma, 73104
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Orlando, Florida, 32803
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Richmond, Virginia, 23235
For information concerning this clinical site, please contact Nymox at 800-936-9669.
San Antonio, Texas, 78229
For information concerning this clinical site, please contact Nymox at 800-936-9669.
San Diego, California, 92103
For information concerning this clinical site, please contact Nymox at 800-936-9669.
San Diego, California, 92120
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Sarasota, Florida, 34237
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Sartell, Minnesota, 56377
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Sewickley, Pennsylvania, 15143
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Southaven, Mississippi, 38671
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Tarzana, California, 91356
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Torrance, California, 90505
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Towson, Maryland, 21204
About this study
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
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.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- NX-1207, Placebo
- Keywords
- Benign prostatic hyperplasia, BPH, Enlarged prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NX-1207Drug
Single intraprostatic injection of 2.5 mg NX-1207
PlaceboDrug
Single intraprostatic injection of placebo
| Study group | Role | What they receive |
|---|---|---|
| NX-1207 | Experimental | Not described Receives: Drug: NX-1207 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Urological Association Symptom Index (AUASI)
Measured: 365 days
Secondary outcomes (6)
American Urological Association Symptom Index (AUASI)
Measured: 90 days
American Urological Association Symptom Index (AUASI)
Measured: 180 days
American Urological Association Symptom Index (AUASI)
Measured: 270 days
Peak urine flow rate (Qmax)
Measured: 365 days
Peak urine flow rate (Qmax)
Measured: 90 days
Peak urine flow rate (Qmax)
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nymox Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945490
- Sponsor's protocol ID
- NX02-0018
- Status last verified
- Mar 2017
- First submitted
- 22 Jul 2009
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00945490
- Acronym / sponsor ID
- NX02-0018
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Keywords
- Benign prostatic hyperplasia, BPH, Enlarged prostate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Nymox CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NX-1207 | Experimental | Drug: NX-1207 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NX-1207Single intraprostatic injection of 2.5 mg NX-1207 | Drug | NX-1207 |
| PlaceboSingle intraprostatic injection of placebo | Drug | Placebo |
Primary outcome
American Urological Association Symptom Index (AUASI)
Time frame: 365 days
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NX-1207 in people with Benign Prostatic Hyperplasia (BPH), run by Nymox Corporation at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Urological Association Symptom Index (AUASI) (time frame: 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.