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Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018

Primary Purpose

Benign Prostatic Hyperplasia (BPH)

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 (BPH) 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. 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

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NX-1207

Placebo

Arm Description

Outcomes

Primary Outcome Measures

American Urological Association Symptom Index (AUASI)

Secondary Outcome Measures

American Urological Association Symptom Index (AUASI)
American Urological Association Symptom Index (AUASI)
American Urological Association Symptom Index (AUASI)
Peak urine flow rate (Qmax)
Peak urine flow rate (Qmax)
Peak urine flow rate (Qmax)

Full Information

First Posted
July 22, 2009
Last Updated
March 9, 2017
Sponsor
Nymox Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00945490
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 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 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 (BPH)
Keywords
Benign prostatic hyperplasia, BPH, Enlarged prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
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
American Urological Association Symptom Index (AUASI)
Time Frame
365 days
Secondary Outcome Measure Information:
Title
American Urological Association Symptom Index (AUASI)
Time Frame
90 days
Title
American Urological Association Symptom Index (AUASI)
Time Frame
180 days
Title
American Urological Association Symptom Index (AUASI)
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 AUASI ≥ 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
Laguna Hills
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
92103
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
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
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
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
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
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
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City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
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City
Sartell
State/Province
Minnesota
ZIP/Postal Code
56377
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
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
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Albany
State/Province
New York
ZIP/Postal Code
12208
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
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City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Sewickley
State/Province
Pennsylvania
ZIP/Postal Code
15143
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
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City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
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) NX02-0018

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