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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nymox Corporation
ClinicalTrials.gov Identifier:
NCT01438775
First received: September 20, 2011
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  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

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.


Estimated Enrollment: 250
Study Start Date: September 2011
Estimated Study Completion Date: November 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
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 23, 2013
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 May 16, 2013