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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00918983
First Posted: June 11, 2009
Last Update Posted: April 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nymox Corporation
  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 Drug: NX-1207 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 NX02-0017

Resource links provided by NLM:


Further study details as provided by Nymox Corporation:

Primary Outcome Measures:
  • International Prostate Symptom Score (IPSS) [ Time Frame: 365 days ]

Secondary Outcome Measures:
  • International Prostate Symptom Score (IPSS) [ Time Frame: 90 days ]
  • International Prostate Symptom Score (IPSS) [ Time Frame: 180 days ]
  • International Prostate Symptom Score (IPSS) [ Time Frame: 270 days ]
  • Peak urine flow rate (Qmax) [ Time Frame: 365 days ]
  • Peak urine flow rate (Qmax) [ Time Frame: 90 days ]
  • Peak urine flow rate (Qmax) [ Time Frame: 180 days ]

Enrollment: 500
Study Start Date: April 2009
Study Completion Date: November 2013
Primary Completion Date: November 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide signed informed consent prior to enrolment in the study
  2. IPSS ≥ 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918983


  Show 41 Study Locations
Sponsors and Collaborators
Nymox Corporation
  More Information

Responsible Party: Nymox Corporation
ClinicalTrials.gov Identifier: NCT00918983     History of Changes
Other Study ID Numbers: NX02-0017
First Submitted: June 9, 2009
First Posted: June 11, 2009
Last Update Posted: April 30, 2014
Last Verified: April 2014

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

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