Benign Prostatic HyperplasiaPhase 3NCT00918983
Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
A Phase 3 study testing NX-1207 in people with Benign Prostatic Hyperplasia, run by Nymox Corporation at 41 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
- 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
- 41 sitesUnited States
- Study dates
- Apr 2009to Nov 2013
- 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
- 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
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
41 sites in 1 country.
41 sites in 1 country
United States41 sites
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Anaheim, California, 92801
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Arlington, Texas, 76017
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Atherton, California, 94027
For information concerning this clinical site, please contact Nymox at 800-936-9669
Atlanta, Georgia, 30308
For information concerning this clinical site, please contact Nymox at 800-936-9669
Bala-Cynwyd, Pennsylvania, 19004
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Bethany, Oklahoma, 73008
For information concerning this clinical site, please contact Nymox at 800-936-9669
Birmingham, Alabama, 35209
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Brooklyn, New York, 11215
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Carrollton, Texas, 75010
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Cincinnati, Ohio, 45212
For information concerning this clinical site, please contact Nymox at 800-936-9669
Columbus, Ohio, 43221
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Concord, North Carolina, 28025
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Dallas, Texas, 75231
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Denver, Colorado, 80211
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Forest Hill, Indiana, 47630
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.
Huntsville, Alabama, 35801
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Jeffersonville, Indiana, 47130
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Knoxville, Tennessee, 37920
For information concerning this clinical site, please contact Nymox at 800-936-9669.
La Mesa, California, 91942
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Lancaster, Pennsylvania, 17604
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Lawrenceville, New Jersey, 08648
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Little Rock, Arkansas, 72211
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Long Beach, California, 90806
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Los Alamitos, California, 90720
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Missoula, Montana, 59802
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Mount Laurel, New Jersey, 08054
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Myrtle Beach, South Carolina, 29572
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Naples, Florida, 34102
For information concerning this clinical site, please contact Nymox at 800-936-9669.
New Britain, Connecticut, 06052
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.
Orlando, Florida, 32806
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Poughkeepsie, New York, 12601
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Raleigh, North Carolina, 27607
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Roswell, Georgia, 30076
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Salem, Oregon, 97301
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Salt Lake City, Utah, 84107
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Shreveport, Louisiana, 71106
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Tallahassee, Florida, 32308
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Tucson, Arizona, 85712
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Voorhees Township, New Jersey, 08043
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 NX02-0017
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
- 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.
International Prostate Symptom Score (IPSS)
Measured: 365 days
Secondary outcomes (6)
International Prostate Symptom Score (IPSS)
Measured: 90 days
International Prostate Symptom Score (IPSS)
Measured: 180 days
International Prostate Symptom Score (IPSS)
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 posted11 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT00918983
- Sponsor's protocol ID
- NX02-0017
- Status last verified
- Apr 2014
- First submitted
- 9 Jun 2009
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. 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 NX02-0017
- ClinicalTrials.gov ID
- NCT00918983
- Acronym / sponsor ID
- NX02-0017
- Conditions
- Benign Prostatic Hyperplasia
- 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
- Apr 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 11 Jun 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
- Double blind (participant, investigator)
- 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
- 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
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
International Prostate Symptom Score (IPSS)
Time frame: 365 days
6 secondary outcomes
International Prostate Symptom Score (IPSS)
Time frame: 90 days
International Prostate Symptom Score (IPSS)
Time frame: 180 days
International Prostate Symptom Score (IPSS)
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 30 Apr 2014.
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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.
41 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, run by Nymox Corporation at 41 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 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 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?
International Prostate Symptom Score (IPSS) (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 30 Apr 2014.