search
Back to results

Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)

Primary Purpose

Benign Prostatic Hyperplasia, BPH, Lower Urinary Tract Symptoms (LUTS)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NX-1207
Sponsored by
Nymox Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign prostatic hyperplasia, BPH, Lower urinary tract symptoms, LUTS, LUTS secondary to BPH, LUTS/BPH, Benign prostatic obstruction (BPO), BPO, Bladder outlet obstruction, BOO

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label Injection of NX-1207

Arm Description

Intraprostatic injection of 2.5 mg NX-1207

Outcomes

Primary Outcome Measures

Safety
Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).

Secondary Outcome Measures

Symptomatic Improvement
Symptomatic improvement as measured by the change in American Urological Association (AUA) Symptom Index from baseline at 90 days. The AUA Symptom Index is a standardized questionnaire that uses seven questions relating to associated BPH symptoms to provide an assessment of symptom severity on a scale from 0 (no symptoms) to 35 (most severe).
Prostate Volume Change
Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography
Change in Urinary Peak Flow
Change in Urinary Peak Flow (Qmax) from baseline to 90 days as determined by urinary flow-rate recording (uroflowmetry).
Symptomatic Improvement
Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days.

Full Information

First Posted
May 1, 2013
Last Updated
March 9, 2017
Sponsor
Nymox Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT01846793
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nymox Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label Injection of NX-1207
Arm Type
Experimental
Arm Description
Intraprostatic injection of 2.5 mg NX-1207
Intervention Type
Drug
Intervention Name(s)
NX-1207
Intervention Description
2.5 mg NX-1207 in 10 mL saline vehicle
Primary Outcome Measure Information:
Title
Safety
Description
Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Symptomatic Improvement
Description
Symptomatic improvement as measured by the change in American Urological Association (AUA) Symptom Index from baseline at 90 days. The AUA Symptom Index is a standardized questionnaire that uses seven questions relating to associated BPH symptoms to provide an assessment of symptom severity on a scale from 0 (no symptoms) to 35 (most severe).
Time Frame
90 days
Title
Prostate Volume Change
Description
Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography
Time Frame
90 days
Title
Change in Urinary Peak Flow
Description
Change in Urinary Peak Flow (Qmax) from baseline to 90 days as determined by urinary flow-rate recording (uroflowmetry).
Time Frame
90 days.
Title
Symptomatic Improvement
Description
Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days.
Time Frame
180 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Laguna Beach
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)

We'll reach out to this number within 24 hrs