A Randomised Phase 3, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-001073-94-DE
• Date of registration: 08/12/2005
• Prospective Registration: No
• Primary sponsor: Threshold Pharmaceuticals, Inc
• Public title: A Randomised Phase 3, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
• Scientific title: A Randomised Phase 3, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
• Date of first enrolment: 21/07/2005
• Target sample size: 480
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001073-94
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany, Hungary, Italy

Key inclusion & exclusion criteria

Inclusion criteria:
Eligible subjects will meet all of the following criteria:

1. Capable of understanding the purpose and risks of the study and sign a statement of informed consent;
2. Male 50 – 80 years of age;
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. I-PSS (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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects will be ineligible for this study based on any one of the following criteria:

1. Prior treatment for BPH with alpha blockers and/or herbal supplements in the past 2 weeks (alpha-blockers and herbal supplements for the treatment of BPH are not allowed during the study);
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:
• Serum creatinine greater than/equal 1.8 mg/dL
• ALT or AST greater than/equal 2.5x the upper limit of normal at screen
• History of active myocardial infarction, unstable cardiac arrhythmias or stroke within 6 months prior to screening
• 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



Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Benign Prostatic Hyperplasia

Intervention(s)

Product Name: Lonidamine
Product Code: TH 070
Pharmaceutical Form: Tablet
CAS Number: 50264-69-2
Current Sponsor code: TH 070
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50 & 150-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Efficacy Measurements:
International prostate symptom score (I-PSS), Qmax on uroflowmetry, micturitional residue, volume of the prostate and PSA;

Safety Measurements:
Adverse events, physical exams (including digital rectal exams, hearing and sensory perception evaluations) and laboratory measurements.

Secondary Objective: To evaluate the efficacy (Qmax on uroflowmetry, post micturitional residue, prostate volume, and PSA), and safety of lonidamine (50 mg, 150 mg) compared to placebo.

Main Objective: To evaluate the efficacy as measured by I-PSS of lonidamine (50 mg, 150 mg) compared to placebo in subjects with symptomatic BPH.

Secondary ID(s)

2005-001073-94-HU

TH-CR-202