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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Nymox Corporation

ClinicalTrials.gov Identifier:

NCT00945490

First received: July 22, 2009

Last updated: May 6, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	July 22, 2009
Last Updated Date	May 6, 2013
Start Date ^ICMJE	May 2009
Estimated Primary Completion Date	April 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 22, 2009)	American Urological Association Symptom Index (AUASI) [ Time Frame: 365 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00945490 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 22, 2009)	American Urological Association Symptom Index (AUASI) [ Time Frame: 90 days ] [ Designated as safety issue: No ] American Urological Association Symptom Index (AUASI) [ Time Frame: 180 days ] [ Designated as safety issue: No ] American Urological Association Symptom Index (AUASI) [ Time Frame: 270 days ] [ Designated as safety issue: No ] Peak urine flow rate (Qmax) [ Time Frame: 365 days ] [ Designated as safety issue: No ] Peak urine flow rate (Qmax) [ Time Frame: 90 days ] [ Designated as safety issue: No ] Peak urine flow rate (Qmax) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018
Official Title ^ICMJE	Phase III Multicenter Prospective Randomized Parallel-Group Placebo-Controlled Double Blind Clinical Evaluation of NX-1207 for the Treatment of BPH NX02-0018
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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Benign Prostatic Hyperplasia (BPH)
Intervention ^ICMJE	Drug: NX-1207 Single intraprostatic injection of 2.5 mg NX-1207 Drug: Placebo Single intraprostatic injection of placebo
Study Arm (s)	Experimental: NX-1207 Intervention: Drug: NX-1207 Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	500
Estimated Completion Date	April 2014
Estimated Primary Completion Date	April 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	45 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00945490
Other Study ID Numbers ^ICMJE	NX02-0018
Has Data Monitoring Committee	No
Responsible Party	Nymox Corporation
Study Sponsor ^ICMJE	Nymox Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Nymox Corporation
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top