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NCT00759135 Clinical Trial

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

Benign Prostatic Hyperplasia (BPH) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00759135
Other study ID # NX02-0016
Secondary ID
Status Completed
Phase Phase 2
First received September 23, 2008
Last updated June 12, 2012
Start date May 2007
Est. completion date May 2008

Study information
Verified date June 2012
Source Nymox Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 85
Est. completion date May 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Male
Age group 45 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 2.5 mg NX-1207
Therapeutic dose; single intraprostatic injection of 2.5 mg NX-1207
• 0.125 mg NX-1207
Low dose; single intraprostatic injection of 0.125 mg NX-1207
• finasteride
Active comparator; 5.0 mg finasteride p.o. q.d. for duration of study (180 days)

Locations
Country Name City State
United States Nymox Investigational Site Anaheim California
United States Nymox Investigational Site Arlington Texas
United States Nymox Investigational Site Atherton California
United States Nymox Investigational Site Brownsville Texas
United States Nymox Investigational Site Dallas Texas
United States Nymox Investigational Site Denver Colorado
United States Nymox Investigational Site Garden City New York
United States Nymox Investigational Site Germantown Tennessee
United States Nymox Investigational Site Greenwood Indiana
United States Nymox Investigational Site Huntsville Alabama
United States Nymox Investigational Site Jeffersonville Indiana
United States Nymox Investigational Site Lancaster Pennsylvania
United States Nymox Investigational Site Las Vegas Nevada
United States Nymox Investigational Site Lawrenceville New Jersey
United States Nymox Investigational Site Little Rock Arkansas
United States Nymox Investigational Site Long Beach California
United States Nymox Investigational Site Marlton New Jersey
United States Nymox Investigational Site McAllen Texas
United States Nymox Investigational Site Missoula Montana
United States Nymox Investigational Site Modesto California
United States Nymox Investigational Site Myrtle Beach South Carolina
United States Nymox Investigational Site New Britain Connecticut
United States Nymox Investigational Site Newport Beach California
United States Nymox Investigational Site Poughkeepsie New York
United States Nymox Investigational Site San Antonio Texas
United States Nymox Investigational Site Sarasota Florida
United States Nymox Investigational Site Shreveport Louisiana
United States Nymox Investigational Site Staten Island New York
United States Nymox Investigational Site Tucson Arizona
United States Nymox Investigational Site Voorhees New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Nymox Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in BPH Symptom Score (AUA SI) 90 days No
Secondary Change in Prostate Volume 90 days No
Secondary Change in Qmax 90 days No
Secondary Change in BPH Symptom Score (AUA SI) 30 days No
Secondary Change in BPH Symptom Score (AUA SI) 180 days No
Secondary Number of Participants with Adverse Events, duration and severity of Adverse Events and relation, if any, to drug 180 days Yes
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Terminated NCT00651807 - A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806) Phase 2
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