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

• Sponsor: Threshold Pharmaceuticals (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00237536
• Collaborator: (none)
• Enrollment: 240
• Locations: 34
• Duration (Months): 14
• Patients Per Site: 7.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia	Drug: Lonidamine	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: Aug 1, 2006
• Actual Study Completion Date: Aug 1, 2006

Outcome Measures

Primary Outcome Measures

1. IPSS []

Secondary Outcome Measures

1. Maximum urinary flow rate (Qmax) []

2. Post-void residual urine volume (PVR) []

3. Prostate volume []

4. Prostate specific antigen (PSA) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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).

1. Active urinary tract infections (UTI)

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

3. Serum creatinine > 1.8 mg/dL

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

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

6. Uncontrolled congestive heart failure

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

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

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

10. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Clinical Therapeutics	Tucson	Arizona	United States	85712
2	Chris B. Threatt, MD Inc.	Atherton	California	United States	94027
3	Urological Sciences Research Foundation	Culver City	California	United States	90232
4	Atlantic Urological Medical Group	Long Beach	California	United States	90806
5	California Professional Research	Newport Beach	California	United States	92660
6	San Diego Uro-Research	San Diego	California	United States	92103
7	Stanford University Hospital	Stanford	California	United States	94305
8	Urology Research Options	Aurora	Colorado	United States	80012
9	Connecticut Clinical Research Center Urology Specialists	Waterbury	Connecticut	United States	06708
10	South Florida Medical Research	Aventura	Florida	United States	33180
11	Tampa Bay Medical Research	Clearwater	Florida	United States	33761
12	Florida Healthcare Research	Ocala	Florida	United States	34474
13	Midwest Prostate & Urology Health Center	Chicago	Illinois	United States	60640
14	Specialty Care Research	Peoria	Illinois	United States	61614
15	Northeast Indiana research, LLC	Fort Wayne	Indiana	United States	46825
16	Metropolitan Urology	Jeffersonville	Indiana	United States	47130
17	Werner, Murdock & Francis, PA, Urology Associates	Greenbelt	Maryland	United States	20770
18	Sheldon J. Freedman, MD Ltd.	Las Vegas	Nevada	United States	89109
19	Delaware Valley Clinical Research	Cherry Hill	New Jersey	United States	08003
20	Lawrenceville Urology	Lawrenceville	New Jersey	United States	08648
21	Urology Healthcare Associates	Westampton	New Jersey	United States	08060
22	Accumed Research Associates	Garden City	New York	United States	11530
23	New York University School of Medicine	New York	New York	United States	10016
24	Weill Medical College of Cornell University	New York	New York	United States	10021
25	Radiant Research. Columbus	Columbus	Ohio	United States	43212
26	Urological Associates of Lancaster	Lancaster	Pennsylvania	United States	17604
27	State College Urologic Associates	State College	Pennsylvania	United States	16801
28	University Urological Research Institute	Providence	Rhode Island	United States	02904
29	Radiant Research, Greer	Greer	South Carolina	United States	29651
30	UT Southwestern Medical Center at Dallas, Dept of Urology	Dallas	Texas	United States	75390
31	Accelovance	Houston	Texas	United States	77024
32	Baylor College of Medicine, Scott Department of Urology	Houston	Texas	United States	77030
33	Urology San Antonio Research	San Antonio	Texas	United States	78229
34	Integrity Medical Research, LLC	Mountlake Terrace	Washington	United States	98043

Sponsors and Collaborators

• Threshold Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00237536
• Other Study ID Numbers: TH-CR-203
• First Posted: Oct 12, 2005
• Last Update Posted: Apr 29, 2009
• Last Verified: Apr 1, 2009

• Keywords provided by , ,: Benign Prostatic Hyperplasia; BPH; Enlarged Prostate
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia; Lonidamine

Study Results

No Results Posted as of Apr 29, 2009