Benign Prostatic Hyperplasia (BPH)Phase 2NCT00759135
Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)
A Phase 2 study testing 2.5 mg NX-1207, 0.125 mg NX-1207 and finasteride in people with Benign Prostatic Hyperplasia (BPH) and Enlarged Prostate, run by Nymox Corporation at 30 sites in United States.
Trial summary
This completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) versus finasteride. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH), Enlarged Prostate
- What is being tested?
- 2.5 mg NX-1207, 0.125 mg NX-1207 and finasteride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 30 sitesUnited States
- Study dates
- May 2007to May 2008
- Phase
- Phase 2
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented history of BPH for at least 1 year
- AUA SI ≥ 15
- Prostate Volume ≥ 30 mL ≤ 70 mL
- Qmax < 15 mL/sec
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
- Surgery or MIST in the previous 12 months for treatment of BPH
- Post-void residual urine volume > 350 mL
- PSA ≥ 10 ng/mL; prostate cancer must be ruled out for PSA ≥ 4 ng/mL
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Nymox Investigational Site
Anaheim, California
Nymox Investigational Site
Arlington, Texas
Nymox Investigational Site
Atherton, California
Nymox Investigational Site
Brownsville, Texas
Nymox Investigational Site
Dallas, Texas
Nymox Investigational Site
Denver, Colorado
Nymox Investigational Site
Garden City, New York
Nymox Investigational Site
Germantown, Tennessee
Nymox Investigational Site
Greenwood, Indiana
Nymox Investigational Site
Huntsville, Alabama
Nymox Investigational Site
Jeffersonville, Indiana
Nymox Investigational Site
Lancaster, Pennsylvania
Nymox Investigational Site
Las Vegas, Nevada
Nymox Investigational Site
Lawrenceville, New Jersey
Nymox Investigational Site
Little Rock, Arkansas
Nymox Investigational Site
Long Beach, California
Nymox Investigational Site
Marlton, New Jersey
Nymox Investigational Site
McAllen, Texas
Nymox Investigational Site
Missoula, Montana
Nymox Investigational Site
Modesto, California
Nymox Investigational Site
Myrtle Beach, South Carolina
Nymox Investigational Site
New Britain, Connecticut
Nymox Investigational Site
Newport Beach, California
Nymox Investigational Site
Poughkeepsie, New York
Nymox Investigational Site
San Antonio, Texas
Nymox Investigational Site
Sarasota, Florida
Nymox Investigational Site
Shreveport, Louisiana
Nymox Investigational Site
Staten Island, New York
Nymox Investigational Site
Tucson, Arizona
Nymox Investigational Site
Voorhees Township, New Jersey
About this study
Official title: Phase 2 Multicenter Randomized Two Dose Level and Non-Inferiority Clinical Evaluation of Transrectal Administration of NX-1207 for the Treatment of BPH
This completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) versus finasteride.
Read the detailed description
Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.
- Being tested
- 2.5 mg NX-1207, 0.125 mg NX-1207, finasteride
- 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.
2.5 mg NX-1207Drug
Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207
0.125 mg NX-1207Drug
Low dose; single intraprostatic injection of 0.125 mg NX-1207
finasterideDrug
Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single therapeutic dose of 2.5 mg NX-1207 Receives: Drug: 2.5 mg NX-1207 |
| 2 | Experimental | Single low dose of 0.125 mg NX-1207 for dose-response evaluation Receives: Drug: 0.125 mg NX-1207 |
| 3 | Active comparator | 5.0 mg finasteride q.d. Receives: Drug: finasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BPH Symptom Score (AUA SI)
Measured: 90 days
Secondary outcomes (5)
Change in Prostate Volume
Measured: 90 days
Change in Qmax
Measured: 90 days
Change in BPH Symptom Score (AUA SI)
Measured: 30 days
Change in BPH Symptom Score (AUA SI)
Measured: 180 days
Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug
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 posted25 Sep 2008 (estimated)
- Study startMay 2007
- Primary completionJan 2008
- Study completionMay 2008
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 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
- NCT00759135
- Sponsor's protocol ID
- NX02-0016
- Status last verified
- Jun 2012
- First submitted
- 23 Sep 2008
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Multicenter Randomized Two Dose Level and Non-Inferiority Clinical Evaluation of Transrectal Administration of NX-1207 for the Treatment of BPH
- ClinicalTrials.gov ID
- NCT00759135
- Acronym / sponsor ID
- NX02-0016
- Keywords
- Benign Prostatic Hyperplasia, BPH, Enlarged Prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Nymox CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 25 Sep 2008 (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 completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) versus finasteride.
Detailed description
Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 2.5 mg NX-1207Single therapeutic dose of 2.5 mg NX-1207 |
| 2 | Experimental | Drug: 0.125 mg NX-1207Single low dose of 0.125 mg NX-1207 for dose-response evaluation |
| 3 | Active comparator | Drug: finasteride5.0 mg finasteride q.d. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented history of BPH for at least 1 year
- AUA SI ≥ 15
- Prostate Volume ≥ 30 mL ≤ 70 mL
- Qmax < 15 mL/sec
Key exclusion criteria (6 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
- Surgery or MIST in the previous 12 months for treatment of BPH
- Post-void residual urine volume > 350 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 |
|---|---|---|
| 2.5 mg NX-1207Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207 | Drug | 1 |
| 0.125 mg NX-1207Low dose; single intraprostatic injection of 0.125 mg NX-1207 | Drug | 2 |
| finasterideActive comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days) | Drug | 3 |
Primary outcome
Change in BPH Symptom Score (AUA SI)
Time frame: 90 days
5 secondary outcomes
Change in Prostate Volume
Time frame: 90 days
Change in Qmax
Time frame: 90 days
Change in BPH Symptom Score (AUA SI)
Time frame: 30 days
Change in BPH Symptom Score (AUA SI)
Time frame: 180 days
Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug
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 14 Jun 2012.
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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.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2.5 mg NX-1207, 0.125 mg NX-1207 and finasteride in people with Benign Prostatic Hyperplasia (BPH) and Enlarged Prostate, run by Nymox Corporation at 30 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 4 inclusion and 6 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 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in BPH Symptom Score (AUA SI) (time frame: 90 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 14 Jun 2012.