Benign Prostatic Hyperplasia Clinical Trial
Official title:
A Randomized Phase 3, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
The purpose of this study is to evaluate the efficacy of lonidamine (50mg, 150mg) compared to placebo in subjects with symptomatic BPH.
Status | Terminated |
Enrollment | 480 |
Est. completion date | December 2006 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Capable of understanding the purpose and risks of the study and sign a statement of informed consent - Male 50-80 years of age - Presence of LUTS (lower urinary tract symptoms) for at least 3 months - Prostate volume measured by TRUS (transrectal ultrasound) > 30 cc - Qmax < 15 mL/sec when measured by uroflowmetry (minimum of 125 mL must be voided) - I-PSS (International prostate symptom score) > 12 - PSA > 1.0 ng/mL - Must ensure and consent to use medically acceptable methods of contraception throughout the entire study with sexual partners of childbearing potential - Able to comply with the prescribed treatment protocol and evaluations Exclusion Criteria: - 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). Prior treatment with 5-alpha-reductase inhibitors is allowed if discontinued at least 3 months prior to enrollment. - Prior surgery of the prostate (except biopsies; subject is eligible to enroll one month after full recovery from prostate biopsy.) - 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.) - Active urinary tract infections (UTI) - 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 at screen 3. History of active myocardial infarction,unstable cardiac arrhythmias or stroke within 6 months prior to screening 4. Uncontrolled congestive heart failure - Uncontrolled diabetes mellitus (fasting blood glucose > 200 mg/dL) - Use of systemic teriods for any reason (systemic steroid usage is not allowed during the study). Inhaled and/or topical steroids are allowed. - Concurrent participation or participation in an investigational drug study within the past 30 days prior to screening - Concomitant disease or condition that could interfere with the conduct of the study, or would in the opinion of the investigator,pose an unnaceptabele risk to the subject |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Vivantes Klinikum am Urban, Klinik für Urologie | Berlin | |
Germany | ClinPharm International GmbH & Co KG--Chemnitz | Chemnitz | |
Germany | ClinPharm International GmbH & Co KG--Dresden | Dresden | |
Germany | niversitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Urologie | Dresden | |
Germany | Gemeinschaftspraxis Jacobi - Hellmis | Duisburg | |
Germany | ClinPharm International GmbH & Co KG--Frankfurt/Main | Frankfurt | |
Germany | ClinPharm International GmbH & Co KG--Gorlitz | Gorlitz | |
Germany | Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Urologie | Hamburg | |
Germany | Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Urologie und Kinderurologie | Kiel | |
Germany | Universitätsklinik Köln, Klinik und Poliklinik für Urologie | Köln | |
Germany | ClinPharm International GmbH & Co KG--Leipzig | Leipzig | |
Germany | ClinPharm International GmbH & Co KG--Magdeburg | Magdeburg | |
Germany | Urologische Universitätsklinik, Klinikum Mannheim gGmbH, Fakultät für Klinische Medizin Mannheim | Mannheim | |
Germany | Klinik für Urologie und Kinderurologie, Klinikum Marburg | Marburg | |
Germany | Klinikum der Universität München, Urologische Klinik und Poliklinik | München | |
Germany | Urologische Klinik und Poliklinik der Technischen Universität München, Klinikum Rechts der Isar | München | |
Germany | Urologische Klinik, Klinikum Landkreis Neumarkt i.d.Obf. | Neumarkt | |
Germany | Klinik für Urologie, Eberhard-Karls-Universität Tübingen | Tubingen | |
Germany | Wuppertaler Gemeinschaftspraxis für Dermatologie, Gynäkologie und Urologie | Wuppertal | |
Hungary | Fovárosi Önkormányzat Jahn Ferenc Dél-Pesti Kórház | Budapest | |
Hungary | Károlyi Sándor Hospital | Budapest | |
Hungary | Semmelweis University | Budapest | |
Hungary | Clinic of Urology | Debrecen | |
Hungary | Dombóvári Szt. Lukács Egészségügyi Közhasznú | Dombóvár | |
Hungary | Petz Aladár County Hospital | Gyor | |
Hungary | Kaposi Mór County Hospital | Kaposvar | |
Hungary | Nagykanizsa Megyei Jogú Város Hospital | Nagykanizsa | |
Hungary | Gróf Esterházy Kórház | Papa | |
Hungary | Dr. Bugyi István Hospital | Szentes | |
Hungary | Saint Bobála Hospital | Tatabánya | |
Italy | A.O. Policlinico di Bari, Clinica Urologica | Bari | |
Italy | A.O. Policlinico di Bari, Clinica Urologica I | Bari | |
Italy | Ospedale S.Annunziata, Unità Operativa di Urologia | Firenze | |
Italy | Università di Genova Ospedale S. Martino, Reparto Urologia | Genova | |
Italy | Ospedale S.Paolo, Cattedra di Urologia | Milano | |
Italy | Università Federico II, Clinica Urologica Edificio 5 | Napoli | |
Italy | Azienda Ospedaliera S.Luigi di Orbassano, Reparto di urologia universitaria | Orbassano | |
Italy | Azienda Ospedaliera, Dipartimento di Urologia | Padova | |
Italy | A.O. Pliclinico Paolo Giaccone, U.O. Urologia con Litotrissia Extracorporea | Palermo | |
Italy | Azienda Ospedaliera Pisana, Dipartimento di Urologia 1 | Pisa | |
Italy | Policlinico Sassarese, Istituto di Clinica Urologica | Sassari | |
Italy | Ospedale Maggiore S.Giovanni Battista, Istituto di Urologia | Torino | |
Italy | Ospedale S.Giovanni Bosco, Dipartimento di Urologia | Torino | |
Poland | Klinika Urologii AM w Bialymstoku | Bialystok | |
Poland | Wojewódzki Szpital Specjalistyczny nr 4 | Bytom | |
Poland | Gabinet Urologiczny | Gdansk | |
Poland | Specjalistyczna Praktyka Lekarska | Katowice | |
Poland | Szpital Specjalistyczny Oddzial Urologii | Koscierzyna | |
Poland | "Specjalista" Spólka z o. o. | Kutno | |
Poland | NZOZ Lekarze Urolodzy, Marek Rozniecki i Partnerzy | Lask | |
Poland | Wojewódzki Szpital,Oddzial i Poradnia Urologiczna | Legnica | |
Poland | Szpital Im. Kardynala Stefana Wyszynskiego, Oddzial Urologii | Lublin | |
Poland | Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka, Oddzial Urologii | Slupsk | |
Poland | Katedra i Klinika Urologii Pomorskiej Akademii Medycznej | Szczecin | |
Poland | Szpital Bielanski, Oddzial Urologii | Warszawa | |
Poland | Szpital Specjalistyczny, Oddzial Urologii | Wejherowo | |
Poland | Katedra i Klinika Urologii AM we Wroclawiu | Wroclaw | |
Poland | Katedra i Klinika Urologii Slaskiej Akademii Medycznej | Zabrze |
Lead Sponsor | Collaborator |
---|---|
Threshold Pharmaceuticals | PRA Health Sciences |
Germany, Hungary, Italy, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | International prostate symptom score (I-PSS) | |||
Secondary | Qmax on uroflowmetry | |||
Secondary | Post micturitional residue | |||
Secondary | Volume of the prostate | |||
Secondary | PSA |
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