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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nymox Corporation
ClinicalTrials.gov Identifier:
NCT00945490
First received: July 22, 2009
Last updated: September 24, 2014
Last verified: September 2014
  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

Resource links provided by NLM:


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 ]

Enrollment: 500
Study Start Date: May 2009
Study Completion Date: May 2014
Primary Completion Date: May 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
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: 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: September 24, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014