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History of Changes for Study: NCT00918983
Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
Latest version (submitted April 1, 2014) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 10, 2009 None (earliest Version on record)
2 June 23, 2009 Contacts/Locations and Study Status
3 August 24, 2009 Contacts/Locations and Study Status
4 September 2, 2009 Contacts/Locations, Study Status and Eligibility
5 September 9, 2009 Contacts/Locations and Study Status
6 September 25, 2009 Contacts/Locations and Study Status
7 October 9, 2009 Study Status and Contacts/Locations
8 October 20, 2009 Contacts/Locations and Study Status
9 October 30, 2009 Contacts/Locations and Study Status
10 December 8, 2009 Study Status
11 March 26, 2010 Study Status
12 March 30, 2010 Contacts/Locations and Study Status
13 May 24, 2010 Study Status and Contacts/Locations
14 July 8, 2010 Study Status and Contacts/Locations
15 August 14, 2010 Study Status
16 October 29, 2010 Study Status
17 February 16, 2011 Study Status
18 May 10, 2011 Study Status
19 September 1, 2011 Study Status and Sponsor/Collaborators
20 November 7, 2011 Study Status and Contacts/Locations
21 December 29, 2011 Study Status
22 March 30, 2012 Study Status
23 July 2, 2012 Study Status
24 August 2, 2012 Study Status
25 September 5, 2012 Study Status
26 October 1, 2012 Study Status
27 October 31, 2012 Study Status
28 December 3, 2012 Recruitment Status, Study Status and Contacts/Locations
29 February 18, 2013 Study Status
30 April 1, 2014 Recruitment Status, Study Status and Study Design
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Study NCT00918983
Submitted Date:  June 10, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: NX02-0017
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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2009
Overall Status: Recruiting
Study Start: April 2009
Primary Completion: November 2010 [Anticipated]
Study Completion: November 2010 [Anticipated]
First Submitted: June 9, 2009
First Submitted that
Met QC Criteria:
June 10, 2009
First Posted: June 11, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 10, 2009
Last Update Posted: June 11, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Nymox Corporation
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign prostatic hyperplasia
BPH
Enlarged prostate
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 500 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. International Prostate Symptom Score (IPSS)
[ Time Frame: 365 days ]

Secondary Outcome Measures:
1. International Prostate Symptom Score (IPSS)
[ Time Frame: 90 days ]

2. International Prostate Symptom Score (IPSS)
[ Time Frame: 180 days ]

3. International Prostate Symptom Score (IPSS)
[ Time Frame: 270 days ]

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

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

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

Open or close this module Eligibility
Minimum Age: 45 Years
Maximum Age: 75 Years
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: There will be multiple sites for this clinical trial. For further information, contact Nymox at
Telephone: 800-936-9669 or at
Email: info@nymox.com
Locations: United States, Alabama
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Recruiting]
Huntsville, Alabama, United States, 35801
United States, Arizona
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Recruiting]
Tucson, Arizona, United States, 85712
United States, Arkansas
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Recruiting]
Little Rock, Arkansas, United States, 72211
United States, California
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Not yet recruiting]
Anaheim, California, United States, 92801
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Recruiting]
Atherton, California, United States, 94027
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Not yet recruiting]
La Mesa, California, United States, 91942
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Recruiting]
Long Beach, California, United States, 90806
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Not yet recruiting]
Los Alamitos, California, United States, 90720
United States, Colorado
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Not yet recruiting]
Denver, Colorado, United States, 80211
United States, Connecticut
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Recruiting]
New Britain, Connecticut, United States, 06052
United States, Florida
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Not yet recruiting]
St. Petersburg, Florida, United States, 33710
United States, Indiana
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Recruiting]
Jeffersonville, Indiana, United States, 47130
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Not yet recruiting]
Newburgh, Indiana, United States, 47630
United States, Louisiana
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Recruiting]
Shreveport, Louisiana, United States, 71106
United States, Montana
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Recruiting]
Missoula, Montana, United States, 59802
United States, New Jersey
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Recruiting]
Lawrenceville, New Jersey, United States, 08648
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Not yet recruiting]
Voorhees, New Jersey, United States, 08043
United States, New York
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Not yet recruiting]
Brooklyn, New York, United States, 11215
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Recruiting]
Garden City, New York, United States, 11530
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Not yet recruiting]
Poughkeepsie, New York, United States, 12601
United States, Ohio
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Not yet recruiting]
Cincinnati, Ohio, United States, 45212
United States, Oregon
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Recruiting]
Salem, Oregon, United States, 97301
United States, Pennsylvania
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Recruiting]
Lancaster, Pennsylvania, United States, 17604-3200
United States, South Carolina
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Recruiting]
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Not yet recruiting]
Knoxville, Tennessee, United States, 37920
United States, Texas
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Recruiting]
Arlington, Texas, United States, 76017
For information concerning this clinical site, please contact Nymox at 800-936-9669
[Recruiting]
Dallas, Texas, United States, 75231
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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