Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Dose Comparison Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00237536
• Other study ID #: TH-CR-203
• Status: Terminated
• Phase: Phase 2
• First received: October 10, 2005
• Last updated: April 28, 2009
• Start date: June 2005
• Est. completion date: August 2006

Study information

• Verified date: April 2009
• Source: Threshold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to evaluate the dose response relationship of lonidamine and the primary efficacy endpoint, International Prostate Symptom Score (IPSS), in subjects with symptomatic benign prostatic hyperplasia (BPH).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 240
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Capable of understanding the purpose and risks of the study and sign a statement of informed consent

2. Male 65-80 years of age (or 40-80 with vasectomy). Vasectomized men must have documentation of azoospermia.

3. Presence of LUTS (lower urinary tract symptoms) for at least 3 months

4. Prostate volume measured by TRUS (transrectal ultrasound) > 30 cc

5. Qmax < 15 mL/sec when measured by uroflowmetry (minimum of 125 mL must be voided)

6. IPSS (International Prostate Symptom Score) > 12

7. PSA > 1.0 ng/mL

8. Must ensure and consent to use medically acceptable methods of contraception throughout the entire study with sexual partners of childbearing potential

9. Able to comply with the prescribed treatment protocol and evaluations

Exclusion Criteria:

1. Prior treatment for BPH with alpha blockers and/or herbal supplements for the treatment of BPH in the past 2 weeks (alpha-blockers and/or herbal supplements for the treatment of BPH are not allowed during the study). Prior treatment with 5-alpha reductase inhibitors is allowed if discontinued at least 3 months prior to enrollment.

2. Prior surgery of the prostate (except biopsies; subject is eligible to enroll one month after full recovery from prostate biopsy.)

3. Current or past evidence of malignant disease of the prostate or prostatic intraepithelial neoplasia (For subjects with PSA between 4 - 10 ng/mL, prostate cancer must be ruled out to the satisfaction of the Principal Investigator. Subjects with PSA >10 ng/mL are excluded).

4. Active urinary tract infections (UTI)

5. Active cardiac, renal or hepatic disease as evidenced by:

1. Serum creatinine > 1.8 mg/dL

2. ALT or AST > 2.5x the upper limit of normal

3. History of active myocardial infarction, unstable cardiac arrhythmias, or stroke within 6 months prior to screening

4. Uncontrolled congestive heart failure

6. Uncontrolled diabetes mellitus (fasting blood glucose > 200 mg/dL)

7. Use of systemic steroids for any reason (systemic steroid usage is not allowed during the study). Inhaled and/or topical steroids are allowed.

8. Concurrent participation or participation in an investigational drug study within the past 30 days prior to screening

9. Concomitant disease or condition that could interfere with the conduct of the study, or would in the opinion of the Investigator, pose an unacceptable risk to the subject

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Lonidamine

Locations

Country	Name	City	State
United States	Chris B. Threatt, MD Inc.	Atherton	California
United States	Urology Research Options	Aurora	Colorado
United States	South Florida Medical Research	Aventura	Florida
United States	Delaware Valley Clinical Research	Cherry Hill	New Jersey
United States	Midwest Prostate & Urology Health Center	Chicago	Illinois
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	Radiant Research. Columbus	Columbus	Ohio
United States	Urological Sciences Research Foundation	Culver City	California
United States	UT Southwestern Medical Center at Dallas, Dept of Urology	Dallas	Texas
United States	Northeast Indiana research, LLC	Fort Wayne	Indiana
United States	Accumed Research Associates	Garden City	New York
United States	Werner, Murdock & Francis, PA, Urology Associates	Greenbelt	Maryland
United States	Radiant Research, Greer	Greer	South Carolina
United States	Accelovance	Houston	Texas
United States	Baylor College of Medicine, Scott Department of Urology	Houston	Texas
United States	Metropolitan Urology	Jeffersonville	Indiana
United States	Urological Associates of Lancaster	Lancaster	Pennsylvania
United States	Sheldon J. Freedman, MD Ltd.	Las Vegas	Nevada
United States	Lawrenceville Urology	Lawrenceville	New Jersey
United States	Atlantic Urological Medical Group	Long Beach	California
United States	Integrity Medical Research, LLC	Mountlake Terrace	Washington
United States	New York University School of Medicine	New York	New York
United States	Weill Medical College of Cornell University	New York	New York
United States	California Professional Research	Newport Beach	California
United States	Florida Healthcare Research	Ocala	Florida
United States	Specialty Care Research	Peoria	Illinois
United States	University Urological Research Institute	Providence	Rhode Island
United States	Urology San Antonio Research	San Antonio	Texas
United States	San Diego Uro-Research	San Diego	California
United States	Stanford University Hospital	Stanford	California
United States	State College Urologic Associates	State College	Pennsylvania
United States	Advanced Clinical Therapeutics	Tucson	Arizona
United States	Connecticut Clinical Research Center Urology Specialists	Waterbury	Connecticut
United States	Urology Healthcare Associates	Westampton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Threshold Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IPSS
Secondary	Maximum urinary flow rate (Qmax)
Secondary	Post-void residual urine volume (PVR)
Secondary	Prostate volume
Secondary	Prostate specific antigen (PSA)