Clinical trial NCT00945490: Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018
Official title: Phase III Multicenter Prospective Randomized Parallel-Group Placebo-Controlled Double Blind Clinical Evaluation of NX-1207 for the Treatment of BPH NX02-0018
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Benign prostatic hyperplasia
BPH
Enlarged prostate
Lead sponsor: Nymox Corporation
Sponsor class: INDUSTRY
First posted: 2009-07-24
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. AUASI ≥ 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: American Urological Association Symptom Index (AUASI)
timeFrame: 365 days
Secondary outcomes:
measure: American Urological Association Symptom Index (AUASI)
timeFrame: 90 days
measure: American Urological Association Symptom Index (AUASI)
timeFrame: 180 days
measure: American Urological Association Symptom Index (AUASI)
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: Laguna Hills
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: California
city: San Diego
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: California
city: San Diego
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: California
city: Tarzana
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: California
city: Torrance
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: Englewood
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Colorado
city: Aventura
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: Sarasota
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Florida
city: Meridian
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Idaho
city: Annapolis
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Maryland
city: Baltimore
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Maryland
city: Glen Burnie
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Maryland
city: Towson
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Maryland
city: Grand Rapids
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669
state: Michigan
city: Sartell
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Minnesota
city: Southaven
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Mississippi
city: Las Vegas
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Nevada
city: Las Vegas
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Nevada
city: Brick
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: New Jersey
city: Albuquerque
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: New Mexico
city: Albany
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: New York
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: New York
city: Bismarck
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: North Dakota
city: Oklahoma City
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Oklahoma
city: Bryn Mawr
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Pennsylvania
city: Sewickley
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Pennsylvania
city: Memphis
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Tennessee
city: Houston
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Texas
city: McAllen
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Texas
city: San Antonio
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Texas
city: Richmond
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Virginia
Study officials:
References: