NCT01438775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 30, 2014

Status Verified

April 1, 2014

Enrollment Period

1.3 years

First QC Date

September 20, 2011

Last Update Submit

April 1, 2014

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign prostatic hyperplasiaBPHEnlarged prostateLower urinary tract symptomsLUTSLUTS secondary to BPHLUTS/BPHBenign prostatic obstructionBPOBladder outlet obstructionBOO

Outcome Measures

Primary Outcomes (1)

  • Safety

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

    180 days

Secondary Outcomes (4)

  • Symptomatic Improvement

    90 days

  • Prostate Volume Change

    90 days

  • Change in Urinary Peak Flow

    90 days

  • Symptomatic Improvement

    180 days

Study Arms (1)

Open Label Injection of NX-1207

EXPERIMENTAL

Intraprostatic injection of 2.5 mg NX-1207

Drug: NX-1207

Interventions

NX-1207DRUG

2.5 mg NX-1207 in 10 mL saline vehicle

Open Label Injection of NX-1207

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

For information concerning this clinical site, please contact Nymox at 800-936-9669.

Huntsville, Alabama, 35801, United States

Location

For information concerning this clinical site, please contact Nymox at 800-936-9669.

Atherton, California, 94027, United States

Location

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San Diego, California, 92103, United States

Location

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Tarzana, California, 91356, United States

Location

For information concerning this clinical site, please contact Nymox at 800-936-9669.

Denver, Colorado, 80211, United States

Location

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Englewood, Colorado, 80113, United States

Location

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New Britain, Connecticut, 06052, United States

Location

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Sarasota, Florida, 34237, United States

Location

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Meridian, Idaho, 83642, United States

Location

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Forest Hill, Indiana, 47630, United States

Location

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Jeffersonville, Indiana, 47130, United States

Location

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Shreveport, Louisiana, 71106, United States

Location

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Annapolis, Maryland, 21401, United States

Location

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Southaven, Mississippi, 38671, United States

Location

For information concerning this clinical site, please contact Nymox at 800-936-9669.

Missoula, Montana, 59808, United States

Location

For information concerning this clinical site, please contact Nymox at 800-936-9669.

Lawrenceville, New Jersey, 08648, United States

Location

For information concerning this clinical site, please contact Nymox at 800-936-9669.

Albuquerque, New Mexico, 87109, United States

Location

For information concerning this clinical site, please contact Nymox at 800-936-9669.

Brooklyn, New York, 11215, United States

Location

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Garden City, New York, 11530, United States

Location

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New York, New York, 10016, United States

Location

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Poughkeepsie, New York, 12601, United States

Location

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Concord, North Carolina, 28025, United States

Location

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Bismarck, North Dakota, 58501, United States

Location

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Lancaster, Pennsylvania, 17604, United States

Location

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Memphis, Tennessee, 38119, United States

Location

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Arlington, Texas, 76017, United States

Location

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Houston, Texas, 77024, United States

Location

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San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Prostatic HyperplasiaLower Urinary Tract SymptomsUrinary Bladder Neck Obstruction

Interventions

fexapotide

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrinary Bladder Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2011

First Posted

September 22, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

April 30, 2014

Record last verified: 2014-04

Locations

US(28)