Clincosm LogoSign in Get a demo

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

Sponsor
Nymox Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01438775
Collaborator
(none)
192
Enrollment
28
Locations
1
Arm
16
Duration (Months)
6.9
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
192 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 3 Multicenter Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX-1207 for the Treatment of BPH: Two Doses 1-7 Years Apart
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Open Label Injection of NX-1207

Intraprostatic injection of 2.5 mg NX-1207

Drug: NX-1207
2.5 mg NX-1207 in 10 mL saline vehicle

Outcome Measures

Primary Outcome Measures

  1. Safety [180 days]

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

Secondary Outcome Measures

  1. Symptomatic Improvement [90 days]

    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).

  2. Prostate Volume Change [90 days]

    Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography

  3. Change in Urinary Peak Flow [90 days]

    Change in Urinary Peak Flow (Qmax) from baseline to 90 days as determined by urinary flow-rate recording (uroflowmetry).

  4. Symptomatic Improvement [180 days]

    Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days.

Eligibility Criteria

Criteria

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

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 For information concerning this clinical site, please contact Nymox at 800-936-9669. Huntsville Alabama United States 35801
2 For information concerning this clinical site, please contact Nymox at 800-936-9669. Atherton California United States 94027
3 For information concerning this clinical site, please contact Nymox at 800-936-9669. San Diego California United States 92103
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. Denver Colorado United States 80211
6 For information concerning this clinical site, please contact Nymox at 800-936-9669. Englewood Colorado United States 80113
7 For information concerning this clinical site, please contact Nymox at 800-936-9669. New Britain Connecticut United States 06052
8 For information concerning this clinical site, please contact Nymox at 800-936-9669 Sarasota Florida United States 34237
9 For information concerning this clinical site, please contact Nymox at 800-936-9669 Meridian Idaho United States 83642
10 For information concerning this clinical site, please contact Nymox at 800-936-9669. Jeffersonville Indiana United States 47130
11 For information concerning this clinical site, please contact Nymox at 800-936-9669 Newburg Indiana United States 47630
12 For information concerning this clinical site, please contact Nymox at 800-936-9669. Shreveport Louisiana United States 71106
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 Southaven Mississippi United States 38671
15 For information concerning this clinical site, please contact Nymox at 800-936-9669. Missoula Montana United States 59808
16 For information concerning this clinical site, please contact Nymox at 800-936-9669. Lawrenceville New Jersey United States 08648
17 For information concerning this clinical site, please contact Nymox at 800-936-9669. Albuquerque New Mexico United States 87109
18 For information concerning this clinical site, please contact Nymox at 800-936-9669. Brooklyn New York United States 11215
19 For information concerning this clinical site, please contact Nymox at 800-936-9669. Garden City New York United States 11530
20 For information concerning this clinical site, please contact Nymox at 800-936-9669. New York New York United States 10016
21 For information concerning this clinical site, please contact Nymox at 800-936-9669. Poughkeepsie New York United States 12601
22 For information concerning this clinical site, please contact Nymox at 800-936-9669 Concord North Carolina United States 28025
23 For information concerning this clinical site, please contact Nymox at 800-936-9669 Bismarck North Dakota United States 58501
24 For information concerning this clinical site, please contact Nymox at 800-936-9669. Lancaster Pennsylvania United States 17604
25 For information concerning this clinical site, please contact Nymox at 800-936-9669. Memphis Tennessee United States 38119
26 For information concerning this clinical site, please contact Nymox at 800-936-9669. Arlington Texas United States 76017
27 For information concerning this clinical site, please contact Nymox at 800-936-9669. Houston Texas United States 77024
28 For information concerning this clinical site, please contact Nymox at 800-936-9669 San Antonio Texas United States 78229

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:
NCT01438775
Other Study ID Numbers:
  • NX02-0020
First Posted:
Sep 22, 2011
Last Update Posted:
Apr 30, 2014
Last Verified:
Apr 1, 2014
Keywords provided by Nymox Corporation
Benign prostatic hyperplasia
BPH
Enlarged prostate
Lower urinary tract symptoms
LUTS
LUTS secondary to BPH
LUTS/BPH
Benign prostatic obstruction
BPO
Bladder outlet obstruction
BOO
Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia

Study Results

No Results Posted as of Apr 30, 2014