Clinical trial NCT01438775: Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
Official title: Phase 3 Multicenter Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX-1207 for the Treatment of BPH: Two Doses 1-7 Years Apart
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign prostatic hyperplasia
BPH
Enlarged prostate
Lower urinary tract symptoms
LUTS
LUTS secondary to BPH
LUTS/BPH
Benign prostatic obstruction
BPO
Bladder outlet obstruction
BOO
Lead sponsor: Nymox Corporation
Sponsor class: INDUSTRY
First posted: 2011-09-22
Enrollment: 192
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Be male aged 45 or older.
* Sign an informed consent form.
* Be in good health.
* Received NX-1207 in a previous completed study 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).

Exclusion Criteria:

* 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
* Urinary tract infection more than once in the past 12 months
* Prostate or bladder cancer.
* 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

Primary outcomes:
measure: Safety
timeFrame: 180 days
Secondary outcomes:
measure: Symptomatic Improvement
timeFrame: 90 days
measure: Prostate Volume Change
timeFrame: 90 days
measure: Change in Urinary Peak Flow
timeFrame: 90 days
measure: Symptomatic Improvement
timeFrame: 180 days
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Alabama
city: Atherton
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: 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: New Britain
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Connecticut
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: 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: Annapolis
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669
state: Maryland
city: Southaven
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669
state: Mississippi
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: Albuquerque
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: New Mexico
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: New York
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: Bismarck
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669
state: North Dakota
city: Lancaster
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: Arlington
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Texas
city: Houston
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
Study officials:
References: