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Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NX-1207
Placebo
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, Enlarged prostate

Eligibility Criteria

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

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

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.
  • 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
  • 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 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NX-1207

Placebo

Arm Description

Outcomes

Primary Outcome Measures

International Prostate Symptom Score (IPSS)

Secondary Outcome Measures

International Prostate Symptom Score (IPSS)
International Prostate Symptom Score (IPSS)
International Prostate Symptom Score (IPSS)
Peak urine flow rate (Qmax)
Peak urine flow rate (Qmax)
Peak urine flow rate (Qmax)

Full Information

First Posted
June 9, 2009
Last Updated
April 1, 2014
Sponsor
Nymox Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00918983
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
Benign prostatic hyperplasia, BPH, Enlarged prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NX-1207
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
NX-1207
Intervention Description
Single intraprostatic injection of 2.5 mg NX-1207
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single intraprostatic injection of placebo
Primary Outcome Measure Information:
Title
International Prostate Symptom Score (IPSS)
Time Frame
365 days
Secondary Outcome Measure Information:
Title
International Prostate Symptom Score (IPSS)
Time Frame
90 days
Title
International Prostate Symptom Score (IPSS)
Time Frame
180 days
Title
International Prostate Symptom Score (IPSS)
Time Frame
270 days
Title
Peak urine flow rate (Qmax)
Time Frame
365 days
Title
Peak urine flow rate (Qmax)
Time Frame
90 days
Title
Peak urine flow rate (Qmax)
Time Frame
180 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provide signed informed consent prior to enrolment in the study IPSS ≥ 15 Prostate Volume ≥ 30 mL ≤ 70 mL Qmax < 15 mL/sec based on a minimum void of 125 mL Agree not to use any other approved or experimental BPH or OAB medication anytime during the study Exclusion Criteria: History of illness or condition that may interfere with study or endanger subject Use of prescribed medications that may interfere with study or endanger subject Presence of a median lobe of the prostate Previous surgery or MIST for treatment of BPH Post-void residual urine volume > 200 mL PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL Participation in a study of any investigational drug or device within the previous 90 days Prostate cancer
Facility Information:
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
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City
Atherton
State/Province
California
ZIP/Postal Code
94027
Country
United States
Facility Name
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City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
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City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
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City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
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City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
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City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
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City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
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City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
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City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
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City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
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City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
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City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
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City
Newburg
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
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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
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Mt. Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
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City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
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City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
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City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
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City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
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City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
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City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
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City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
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City
Bethany
State/Province
Oklahoma
ZIP/Postal Code
73008
Country
United States
Facility Name
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City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
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City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
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City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
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City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
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City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
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City
Arlington
State/Province
Texas
ZIP/Postal Code
76017
Country
United States
Facility Name
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City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
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City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
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City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)

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