Clinical trial NCT01846793: Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)
Official title: Phase 3 Multicenter Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX-1207 for the Treatment of BPH: Two Doses 1-8 Years Apart
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
BPH
Lower Urinary Tract Symptoms (LUTS)
LUTS
Keywords: Benign prostatic hyperplasia
BPH
Lower urinary tract symptoms
LUTS
LUTS secondary to BPH
LUTS/BPH
Benign prostatic obstruction (BPO)
BPO
Bladder outlet obstruction
BOO
Lead sponsor: Nymox Corporation
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 160
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 (other than NX02-0020) 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.
* Prostate-Specific Antigen (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: Laguna Beach
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: Aventura
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Florida
city: Naples
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: 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: 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: Missoula
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Montana
city: Brick
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: New Jersey
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: Columbus
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Ohio
city: Dallas
country: United States
facility: For information concerning this clinical site, please contact Nymox at 800-936-9669.
state: Texas
Study officials:
References: