Benign Prostatic HyperplasiaPhase 3NCT01846793
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)
A Phase 3 study testing NX-1207 in people with Benign Prostatic Hyperplasia and BPH, run by Nymox Corporation at 17 sites in United States.
Trial summary
This study is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207. 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, Lower Urinary Tract Symptoms (LUTS)
- What is being tested?
- NX-1207
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 17 sitesUnited States
- Study dates
- Apr 2013to Oct 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
- Be male aged 45 or older.
- Sign an informed consent form.
- Be in good health.
- Received NX-1207 in a previous completed study (other than NX02-0020) or received NX-1207 or placebo in a concurrent U.S. study (NX02-0017 and NX02-0018) and completed their V10 (365 day) visit.
- Have Prostate Gland Volume ≥ 25 mL (25 g).
Who cannot join
- Surgery or minimally invasive surgical therapy (MIST) for treatment of BPH after first NX-1207 injection
- Post-void residual urine volume > 200 mL
- Presence of a symptomatic median lobe of the prostate
- History of use of self-catheterization for urinary retention.
- Urinary retention in the previous 12 months.
- Prostatitis
Show all 13Show fewer
- Urinary tract infection more than once in the past 12 months
- Prostate or bladder cancer.
- Prostate-Specific Antigen (PSA) ≥ 10 ng/mL
- Poorly controlled diabetes
- History or evidence of illness or condition that may interfere with study or endanger subject
- Participation in a study of any investigational drug (other than NX-1207) or investigational device within the previous 90 days
- Use of specific prescribed medications that may interfere with study or endanger subject
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
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.
Brick, New Jersey, 08724
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.
Dallas, Texas, 75010
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.
Jeffersonville, Indiana, 47130
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Laguna Beach, California, 92653
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.
Missoula, Montana, 59808
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 York, New York, 10016
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.
Shreveport, Louisiana, 71106
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Towson, Maryland, 21204
About this study
Official title: Phase 3 Multicenter Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX-1207 for the Treatment of BPH: Two Doses 1-8 Years Apart
This study is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.
- Being tested
- NX-1207
- Keywords
- Benign prostatic hyperplasia, BPH, Lower urinary tract symptoms, LUTS, LUTS secondary to BPH, LUTS/BPH, Benign prostatic obstruction (BPO), BPO, Bladder outlet obstruction, BOO
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Urinary Bladder Neck Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NX-1207Drug
2.5 mg NX-1207 in 10 mL saline vehicle
| Study group | Role | What they receive |
|---|---|---|
| Open Label Injection of NX-1207 | Experimental | Intraprostatic injection of 2.5 mg NX-1207 Receives: Drug: NX-1207 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).
Measured: 180 days
Secondary outcomes (4)
Symptomatic Improvement
Symptomatic improvement as measured by the change in American Urological Association (AUA) Symptom Index from baseline at 90 days. The AUA Symptom Index is a standardized questionnaire that uses seven questions relating to associated BPH symptoms to provide an assessment of symptom severity on a scale from 0 (no symptoms) to 35 (most severe).
Measured: 90 days
Prostate Volume Change
Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography
Measured: 90 days
Change in Urinary Peak Flow
Change in Urinary Peak Flow (Qmax) from baseline to 90 days as determined by urinary flow-rate recording (uroflowmetry).
Measured: 90 days.
Symptomatic Improvement
Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days.
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 posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2014
- Study completionOct 2014
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 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
- NCT01846793
- Sponsor's protocol ID
- NX02-0022
- Status last verified
- Mar 2017
- First submitted
- 1 May 2013
- 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 3 Multicenter Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX-1207 for the Treatment of BPH: Two Doses 1-8 Years Apart
- ClinicalTrials.gov ID
- NCT01846793
- Acronym / sponsor ID
- NX02-0022
- Keywords
- Benign prostatic hyperplasia, BPH, Lower urinary tract symptoms, LUTS, LUTS secondary to BPH, LUTS/BPH, Benign prostatic obstruction (BPO), BPO
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Nymox CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 May 2013 (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 is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Injection of NX-1207 | Experimental | Drug: NX-1207Intraprostatic injection of 2.5 mg NX-1207 |
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)
- Be male aged 45 or older.
- Sign an informed consent form.
- Be in good health.
- Received NX-1207 in a previous completed study (other than NX02-0020) or received NX-1207 or placebo in a concurrent U.S. study (NX02-0017 and NX02-0018) and completed their V10 (365 day) visit.
- Have Prostate Gland Volume ≥ 25 mL (25 g).
Key exclusion criteria (13 listed)
- Surgery or minimally invasive surgical therapy (MIST) for treatment of BPH after first NX-1207 injection
- Post-void residual urine volume > 200 mL
- Presence of a symptomatic median lobe of the prostate
- History of use of self-catheterization for urinary retention.
- Urinary retention in the previous 12 months.
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-12072.5 mg NX-1207 in 10 mL saline vehicle | Drug | Open Label Injection of NX-1207 |
Primary outcome
Safety
Time frame: 180 days
Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).
4 secondary outcomes
Symptomatic Improvement
Time frame: 90 days
Prostate Volume Change
Time frame: 90 days
Change in Urinary Peak Flow
Time frame: 90 days.
Symptomatic Improvement
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.
17 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 and BPH, run by Nymox Corporation at 17 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 13 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 17 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. 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?
Safety (time frame: 180 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.