Benign Prostatic Hyperplasia
Conditions
Interventions
Product Name: Lonidamine
Product Code: TH 070
Pharmaceutical Form: Tablet
CAS Number: 50264-69-2
Current Sponsor code: TH 070
Other descriptive name: Angelini/ACRAF code AF1890, Lonidamina
Concentrati
Sponsors
Threshold Pharmaceuticals Inc
Eligibility
Sex/Gender
Male
Inclusion 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 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
Exclusion criteria: Subjects will be ineligible for this study based on any one of the following criteria: 1. Prior treatment for BPH other than alpha blockers (alpha-blockers are not allowed during the study) 2. Prior surgery of the prostate (except biopsies) 3. Current or past evidence of malignant disease of the prostate or prostatic intraepithelial neoplasia (subjects with PSA > 4 ng/mL must have had a negative biopsy within one year prior to enrollment or should undergo ultrasound–guided prostate biopsy to rule out malignant or pre-malignant prostate disease. Subject is eligible to enroll after one month from full recovery) 4. Active urinary tract infections (UTI) 5. Active cardiac, renal or hepatic disease as evidenced by: • Serum creatinine > 1.8 mg/dL • ALT or AST > 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 steroids for any reason (steroid usage is not allowed during the study) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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;Primary end point(s): Efficacy - International prostate symptom score (I-PSS), Qmax on uroflowmetry, post micturitional residue, volume of the prostate and PSA Safety - Adverse events, physical exams (including digital rectal exams, hearing and sensory perception evaluations) and laboratory measurements | — |
Countries
Germany, Hungary, Italy
Outcome results
None listed