NCT00918983

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_3

Geographic Reach
1 country

41 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

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

April 30, 2014

Status Verified

April 1, 2014

Enrollment Period

4.6 years

First QC Date

June 9, 2009

Last Update Submit

April 1, 2014

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign prostatic hyperplasiaBPHEnlarged prostate

Outcome Measures

Primary Outcomes (1)

  • International Prostate Symptom Score (IPSS)

    365 days

Secondary Outcomes (6)

  • International Prostate Symptom Score (IPSS)

    90 days

  • International Prostate Symptom Score (IPSS)

    180 days

  • International Prostate Symptom Score (IPSS)

    270 days

  • Peak urine flow rate (Qmax)

    365 days

  • Peak urine flow rate (Qmax)

    90 days

  • +1 more secondary outcomes

Study Arms (2)

NX-1207

EXPERIMENTAL
Drug: NX-1207

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

NX-1207DRUG

Single intraprostatic injection of 2.5 mg NX-1207

NX-1207
PlaceboDRUG

Single intraprostatic injection of placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • Provide signed informed consent prior to enrolment in the study
  • IPSS ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

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

Birmingham, Alabama, 35209, United States

Location

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Huntsville, Alabama, 35801, United States

Location

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Tucson, Arizona, 85712, United States

Location

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Little Rock, Arkansas, 72211, United States

Location

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Anaheim, California, 92801, United States

Location

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Atherton, California, 94027, United States

Location

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La Mesa, California, 91942, United States

Location

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Long Beach, California, 90806, United States

Location

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Los Alamitos, California, 90720, United States

Location

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Denver, Colorado, 80211, United States

Location

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New Britain, Connecticut, 06052, United States

Location

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Naples, Florida, 34102, United States

Location

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Ocala, Florida, 34474, United States

Location

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Orlando, Florida, 32806, United States

Location

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Tallahassee, Florida, 32308, United States

Location

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Atlanta, Georgia, 30308, United States

Location

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Roswell, Georgia, 30076, 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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Missoula, Montana, 59802, United States

Location

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Lawrenceville, New Jersey, 08648, United States

Location

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Mount Laurel, New Jersey, 08054, United States

Location

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Voorhees Township, New Jersey, 08043, United States

Location

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Brooklyn, New York, 11215, United States

Location

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Garden City, New York, 11530, 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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Raleigh, North Carolina, 27607, United States

Location

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Cincinnati, Ohio, 45212, United States

Location

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Columbus, Ohio, 43221, United States

Location

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Bethany, Oklahoma, 73008, United States

Location

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Salem, Oregon, 97301, United States

Location

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Bala-Cynwyd, Pennsylvania, 19004, United States

Location

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Lancaster, Pennsylvania, 17604, United States

Location

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Myrtle Beach, South Carolina, 29572, United States

Location

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Knoxville, Tennessee, 37920, United States

Location

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Arlington, Texas, 76017, United States

Location

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Carrollton, Texas, 75010, United States

Location

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Dallas, Texas, 75231, United States

Location

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Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

fexapotide

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 11, 2009

Study Start

April 1, 2009

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

April 30, 2014

Record last verified: 2014-04

Locations

US(41)