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Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nymox Corporation
ClinicalTrials.gov Identifier:
NCT00945490
First received: July 22, 2009
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia (BPH)
 Drug: NX-1207
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Multicenter Prospective Randomized Parallel-Group Placebo-Controlled Double Blind Clinical Evaluation of NX-1207 for the Treatment of BPH NX02-0018

Further study details as provided by Nymox Corporation:

Primary Outcome Measures:
  • American Urological Association Symptom Index (AUASI) [ Time Frame: 365 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • American Urological Association Symptom Index (AUASI) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • American Urological Association Symptom Index (AUASI) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • American Urological Association Symptom Index (AUASI) [ Time Frame: 270 days ] [ Designated as safety issue: No ]
  • Peak urine flow rate (Qmax) [ Time Frame: 365 days ] [ Designated as safety issue: No ]
  • Peak urine flow rate (Qmax) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Peak urine flow rate (Qmax) [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: May 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NX-1207 Drug: NX-1207
Single intraprostatic injection of 2.5 mg NX-1207
Placebo Comparator: Placebo Drug: Placebo
Single intraprostatic injection of placebo

  Eligibility

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

Inclusion Criteria:

  1. Provide signed informed consent prior to enrolment in the study
  2. AUASI ≥ 15
  3. Prostate Volume ≥ 30 mL ≤ 70 mL
  4. Qmax < 15 mL/sec based on a minimum void of 125 mL
  5. Agree not to use any other approved or experimental BPH or OAB medication anytime during the study

Exclusion Criteria:

  1. History of illness or condition that may interfere with study or endanger subject
  2. Use of prescribed medications that may interfere with study or endanger subject
  3. Presence of a median lobe of the prostate
  4. Previous surgery or MIST for treatment of BPH
  5. Post-void residual urine volume > 200 mL
  6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL
  7. Participation in a study of any investigational drug or device within the previous 90 days
  8. Prostate cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945490

  Show 35 Study Locations
Sponsors and Collaborators
Nymox Corporation
  More Information

No publications provided

Responsible Party: Nymox Corporation
ClinicalTrials.gov Identifier: NCT00945490     History of Changes
Other Study ID Numbers: NX02-0018
Study First Received: July 22, 2009
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Nymox Corporation:
Benign prostatic hyperplasia
BPH
Enlarged prostate

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013