Clinical trial NCT00918983: Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign prostatic hyperplasia
BPH
Enlarged prostate
Lead sponsor: Nymox Corporation
Sponsor class: INDUSTRY
First posted: 2009-06-11
Enrollment: 500
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Provide signed informed consent prior to enrolment in the study
2. IPSS ≥ 15
3. Prostate Volume ≥ 30 mL ≤ 70 mL
4. Qmax \< 15 mL/sec based on a minimum void of 125 mL
5. Agree not to use any other approved or experimental BPH or OAB medication anytime during the study

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. Previous surgery or MIST for treatment of BPH
5. Post-void residual urine volume \> 200 mL
6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL
7. Participation in a study of any investigational drug or device within the previous 90 days
8. Prostate cancer

Primary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: 365 days
Secondary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: 90 days
measure: International Prostate Symptom Score (IPSS)
timeFrame: 180 days
measure: International Prostate Symptom Score (IPSS)
timeFrame: 270 days
measure: Peak urine flow rate (Qmax)
timeFrame: 365 days
measure: Peak urine flow rate (Qmax)
timeFrame: 90 days
measure: Peak urine flow rate (Qmax)
timeFrame: 180 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669
state: Alabama
city: Huntsville
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Alabama
city: Tucson
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Arizona
city: Little Rock
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Arkansas
city: Anaheim
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: California
city: Atherton
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: California
city: La Mesa
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: California
city: Long Beach
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: California
city: Los Alamitos
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: California
city: Denver
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Colorado
city: New Britain
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Connecticut
city: Naples
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Florida
city: Ocala
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Florida
city: Orlando
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Florida
city: Tallahassee
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Florida
city: Atlanta
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669
state: Georgia
city: Roswell
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Georgia
city: Jeffersonville
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Indiana
city: Newburg
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Indiana
city: Shreveport
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Louisiana
city: Missoula
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Montana
city: Lawrenceville
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: New Jersey
city: Mt. Laurel
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: New Jersey
city: Voorhees
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: New Jersey
city: Brooklyn
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: New York
city: Garden City
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: New York
city: Poughkeepsie
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: New York
city: Concord
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: North Carolina
city: Raleigh
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: North Carolina
city: Cincinnati
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Ohio
city: Columbus
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669
state: Ohio
city: Bethany
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Oklahoma
city: Salem
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Oregon
city: Bala Cynwyd
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669
state: Pennsylvania
city: Lancaster
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: South Carolina
city: Knoxville
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Tennessee
city: Arlington
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Texas
city: Carrollton
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Texas
city: Dallas
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Texas
city: Salt Lake City
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Utah
Study officials:
References: