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

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ClinicalTrials.gov Identifier: NCT00945490
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Nymox Corporation

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : May 2009
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. American Urological Association Symptom Index (AUASI) [ Time Frame: 365 days ]

Secondary Outcome Measures :
  1. American Urological Association Symptom Index (AUASI) [ Time Frame: 90 days ]
  2. American Urological Association Symptom Index (AUASI) [ Time Frame: 180 days ]
  3. American Urological Association Symptom Index (AUASI) [ Time Frame: 270 days ]
  4. Peak urine flow rate (Qmax) [ Time Frame: 365 days ]
  5. Peak urine flow rate (Qmax) [ Time Frame: 90 days ]
  6. Peak urine flow rate (Qmax) [ Time Frame: 180 days ]


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. 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

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): NCT00945490


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Sponsors and Collaborators
Nymox Corporation

Responsible Party: Nymox Corporation
ClinicalTrials.gov Identifier: NCT00945490     History of Changes
Other Study ID Numbers: NX02-0018
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017

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