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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nymox Corporation
ClinicalTrials.gov Identifier:
NCT01438775
First received: September 20, 2011
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Benign Prostatic Hyperplasia
Drug: NX-1207
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nymox Corporation:

Primary Outcome Measures:
  • Safety [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).


Secondary Outcome Measures:
  • Symptomatic Improvement [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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).

  • Prostate Volume Change [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Change in prostate volume from baseline to 90 days as measured by transrectal ultrasonography

  • Change in Urinary Peak Flow [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Change in Urinary Peak Flow (Qmax) from baseline to 90 days as determined by urinary flow-rate recording (uroflowmetry).

  • Symptomatic Improvement [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    Symptomatic improvement as measured by the change in AUA Symptom Index from baseline at 180 days.


Enrollment: 192
Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438775

  Show 28 Study Locations
Sponsors and Collaborators
Nymox Corporation
  More Information

No publications provided

Responsible Party: Nymox Corporation
ClinicalTrials.gov Identifier: NCT01438775     History of Changes
Other Study ID Numbers: NX02-0020
Study First Received: September 20, 2011
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration

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
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014