Clinical trial NCT00759135: Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Benign Prostatic Hyperplasia (BPH)
Enlarged Prostate
Keywords: Benign Prostatic Hyperplasia
BPH
Enlarged Prostate
Lead sponsor: Nymox Corporation
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 85
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.

Eligibility criteria: Inclusion Criteria:

1. Documented history of BPH for at least 1 year
2. AUA SI ≥ 15
3. Prostate Volume ≥ 30 mL ≤ 70 mL
4. Qmax \< 15 mL/sec

Exclusion Criteria:

1. History of illness or condition that may interfere with study or endanger subject
2. Use of prescribed medications that may interfere with study or endanger subject
3. Presence of a median lobe of the prostate
4. Surgery or MIST in the previous 12 months for treatment of BPH
5. Post-void residual urine volume \> 350 mL
6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out for PSA ≥ 4 ng/mL

Primary outcomes:
measure: Change in BPH Symptom Score (AUA SI)
timeFrame: 90 days
Secondary outcomes:
measure: Change in Prostate Volume
timeFrame: 90 days
measure: Change in Qmax
timeFrame: 90 days
measure: Change in BPH Symptom Score (AUA SI)
timeFrame: 30 days
measure: Change in BPH Symptom Score (AUA SI)
timeFrame: 180 days
measure: Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug
timeFrame: 180 days
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Nymox Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Nymox Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Nymox Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Nymox Investigational Site
state: California
city: Atherton
country: United States
facility: Nymox Investigational Site
state: California
city: Long Beach
country: United States
facility: Nymox Investigational Site
state: California
city: Modesto
country: United States
facility: Nymox Investigational Site
state: California
city: Newport Beach
country: United States
facility: Nymox Investigational Site
state: California
city: Denver
country: United States
facility: Nymox Investigational Site
state: Colorado
city: New Britain
country: United States
facility: Nymox Investigational Site
state: Connecticut
city: Sarasota
country: United States
facility: Nymox Investigational Site
state: Florida
city: Greenwood
country: United States
facility: Nymox Investigational Site
state: Indiana
city: Jeffersonville
country: United States
facility: Nymox Investigational Site
state: Indiana
city: Shreveport
country: United States
facility: Nymox Investigational Site
state: Louisiana
city: Missoula
country: United States
facility: Nymox Investigational Site
state: Montana
city: Las Vegas
country: United States
facility: Nymox Investigational Site
state: Nevada
city: Lawrenceville
country: United States
facility: Nymox Investigational Site
state: New Jersey
city: Marlton
country: United States
facility: Nymox Investigational Site
state: New Jersey
city: Voorhees
country: United States
facility: Nymox Investigational Site
state: New Jersey
city: Garden City
country: United States
facility: Nymox Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Nymox Investigational Site
state: New York
city: Staten Island
country: United States
facility: Nymox Investigational Site
state: New York
city: Lancaster
country: United States
facility: Nymox Investigational Site
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Nymox Investigational Site
state: South Carolina
city: Germantown
country: United States
facility: Nymox Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: Nymox Investigational Site
state: Texas
city: Brownsville
country: United States
facility: Nymox Investigational Site
state: Texas
city: Dallas
country: United States
facility: Nymox Investigational Site
state: Texas
city: McAllen
country: United States
facility: Nymox Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Nymox Investigational Site
state: Texas
Study officials:
References: