E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Benign Prostatic Hyperplasia |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy as measured by I-PSS of lonidamine (50 mg, 150 mg) compared to placebo in subjects with symptomatic BPH. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |