Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nymox Corporation
ClinicalTrials.gov Identifier:
NCT00759135
First received: September 23, 2008
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

This completed study evaluated the safety and efficacy of two dose levels of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) versus finasteride.


Condition Intervention Phase
Benign Prostatic Hyperplasia (BPH)
Enlarged Prostate
Drug: 2.5 mg NX-1207
Drug: 0.125 mg NX-1207
Drug: finasteride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase 2 Multicenter Randomized Two Dose Level and Non-Inferiority Clinical Evaluation of Transrectal Administration of NX-1207 for the Treatment of BPH

Resource links provided by NLM:


Further study details as provided by Nymox Corporation:

Primary Outcome Measures:
  • Change in BPH Symptom Score (AUA SI) [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Prostate Volume [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Change in Qmax [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Change in BPH Symptom Score (AUA SI) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Change in BPH Symptom Score (AUA SI) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

Enrollment: 85
Study Start Date: May 2007
Study Completion Date: May 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Single therapeutic dose of 2.5 mg NX-1207
Drug: 2.5 mg NX-1207
Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207
Experimental: 2
Single low dose of 0.125 mg NX-1207 for dose-response evaluation
Drug: 0.125 mg NX-1207
Low dose; single intraprostatic injection of 0.125 mg NX-1207
Active Comparator: 3
5.0 mg finasteride q.d.
Drug: finasteride
Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)

Detailed Description:

Subjects randomized to NX-1207 were blinded as to the dose level of NX-1207 they received.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Documented history of BPH for at least 1 year
  2. AUA SI ≥ 15
  3. Prostate Volume ≥ 30 mL ≤ 70 mL
  4. Qmax < 15 mL/sec

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. Surgery or MIST in the previous 12 months for treatment of BPH
  5. Post-void residual urine volume > 350 mL
  6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out for PSA ≥ 4 ng/mL
  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: NCT00759135

  Show 30 Study Locations
Sponsors and Collaborators
Nymox Corporation
  More Information

No publications provided

Responsible Party: Nymox Corporation
ClinicalTrials.gov Identifier: NCT00759135     History of Changes
Other Study ID Numbers: NX02-0016
Study First Received: September 23, 2008
Last Updated: June 12, 2012
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
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Finasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014