Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)

Phase 3

Completed

• Conditions: BPH; LUTS; Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms (LUTS)
• Interventions: Drug: NX-1207

• Registration Number: NCT01846793
• Lead Sponsor: Nymox Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-01
• Study First Posted: 2013-05-03
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2017-03
• Disposition First Submitted: 2017-03-09
• Disposition First Submitted QC: 2017-03-09
• Last Update Submitted: 2017-03-09
• Disposition First Posted: 2017-03-10
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 160

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 (other than NX02-0020) 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.
• Prostate-Specific Antigen (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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Injection of NX-1207	NX-1207	Intraprostatic injection of 2.5 mg NX-1207

Primary Outcome Measures

Name	Time	Method
Safety	180 days	Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).

Secondary Outcome Measures

Name	Time	Method
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).
Prostate Volume Change	90 days	Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography
Symptomatic Improvement	180 days	Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days.

Trial Locations

Locations (1)

For information concerning this clinical site, please contact Nymox at 800-936-9669.; 🇺🇸 Dallas, Texas, United States