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

Sponsor
Nymox Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00945490
Collaborator
(none)
500
Enrollment
35
Locations
2
Arms
60
Duration (Months)
14.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
May 1, 2009
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: NX-1207

Drug: NX-1207
Single intraprostatic injection of 2.5 mg NX-1207
Placebo Comparator: Placebo

Drug: Placebo
Single intraprostatic injection of placebo

Outcome Measures

Primary Outcome Measures

  1. American Urological Association Symptom Index (AUASI) [365 days]

Secondary Outcome Measures

  1. American Urological Association Symptom Index (AUASI) [90 days]

  2. American Urological Association Symptom Index (AUASI) [180 days]

  3. American Urological Association Symptom Index (AUASI) [270 days]

  4. Peak urine flow rate (Qmax) [365 days]

  5. Peak urine flow rate (Qmax) [90 days]

  6. Peak urine flow rate (Qmax) [180 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 For information concerning this clinical site, please contact Nymox at 800-936-9669. Laguna Hills California United States 92653
2 For information concerning this clinical site, please contact Nymox at 800-936-9669. San Diego California United States 92103
3 For information concerning this clinical site, please contact Nymox at 800-936-9669. San Diego California United States 92120
4 For information concerning this clinical site, please contact Nymox at 800-936-9669. Tarzana California United States 91356
5 For information concerning this clinical site, please contact Nymox at 800-936-9669. Torrance California United States 90505
6 For information concerning this clinical site, please contact Nymox at 800-936-9669. Denver Colorado United States 80220
7 For information concerning this clinical site, please contact Nymox at 800-936-9669. Englewood Colorado United States 80113
8 For information concerning this clinical site, please contact Nymox at 800-936-9669. Aventura Florida United States 33180
9 For information concerning this clinical site, please contact Nymox at 800-936-9669. Ocala Florida United States 34474
10 For information concerning this clinical site, please contact Nymox at 800-936-9669. Orlando Florida United States 32803
11 For information concerning this clinical site, please contact Nymox at 800-936-9669. Sarasota Florida United States 34237
12 For information concerning this clinical site, please contact Nymox at 800-936-9669. Meridian Idaho United States 83642
13 For information concerning this clinical site, please contact Nymox at 800-936-9669. Annapolis Maryland United States 21401
14 For information concerning this clinical site, please contact Nymox at 800-936-9669. Baltimore Maryland United States 21237
15 For information concerning this clinical site, please contact Nymox at 800-936-9669. Glen Burnie Maryland United States 21061
16 For information concerning this clinical site, please contact Nymox at 800-936-9669. Towson Maryland United States 21204
17 For information concerning this clinical site, please contact Nymox at 800-936-9669 Grand Rapids Michigan United States 49546
18 For information concerning this clinical site, please contact Nymox at 800-936-9669. Sartell Minnesota United States 56377
19 For information concerning this clinical site, please contact Nymox at 800-936-9669. Southaven Mississippi United States 38671
20 For information concerning this clinical site, please contact Nymox at 800-936-9669. Las Vegas Nevada United States 89146
21 For information concerning this clinical site, please contact Nymox at 800-936-9669. Las Vegas Nevada United States 89148
22 For information concerning this clinical site, please contact Nymox at 800-936-9669. Brick New Jersey United States 08724
23 For information concerning this clinical site, please contact Nymox at 800-936-9669. Albuquerque New Mexico United States 87109
24 For information concerning this clinical site, please contact Nymox at 800-936-9669. Albany New York United States 12208
25 For information concerning this clinical site, please contact Nymox at 800-936-9669. Garden City New York United States 11530
26 For information concerning this clinical site, please contact Nymox at 800-936-9669. New York New York United States 10016
27 For information concerning this clinical site, please contact Nymox at 800-936-9669. Bismarck North Dakota United States 58501
28 For information concerning this clinical site, please contact Nymox at 800-936-9669. Oklahoma City Oklahoma United States 73104
29 For information concerning this clinical site, please contact Nymox at 800-936-9669. Bryn Mawr Pennsylvania United States 19010
30 For information concerning this clinical site, please contact Nymox at 800-936-9669. Sewickley Pennsylvania United States 15143
31 For information concerning this clinical site, please contact Nymox at 800-936-9669. Memphis Tennessee United States 38119
32 For information concerning this clinical site, please contact Nymox at 800-936-9669. Houston Texas United States 77024
33 For information concerning this clinical site, please contact Nymox at 800-936-9669. McAllen Texas United States 78503
34 For information concerning this clinical site, please contact Nymox at 800-936-9669. San Antonio Texas United States 78229
35 For information concerning this clinical site, please contact Nymox at 800-936-9669. Richmond Virginia United States 23235

Sponsors and Collaborators

  • Nymox Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nymox Corporation
ClinicalTrials.gov Identifier:
NCT00945490
Other Study ID Numbers:
  • NX02-0018
First Posted:
Jul 24, 2009
Last Update Posted:
Mar 10, 2017
Last Verified:
Mar 1, 2017
Keywords provided by Nymox Corporation
Benign prostatic hyperplasia
BPH
Enlarged prostate
Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia

Study Results

No Results Posted as of Mar 10, 2017