Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
NCT ID: NCT00435448
Last Updated: 2009-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
480 participants
INTERVENTIONAL
2005-06-30
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Interventions
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Lonidamine
Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
80 Years
MALE
No
Sponsors
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PRA Health Sciences
INDUSTRY
Threshold Pharmaceuticals
INDUSTRY
Principal Investigators
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Peter Alken, MD
Role: PRINCIPAL_INVESTIGATOR
Fakultät für Klinische Medizin Mannheim
Locations
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Vivantes Klinikum am Urban, Klinik für Urologie
Berlin, , Germany
ClinPharm International GmbH & Co KG--Chemnitz
Chemnitz, , Germany
Universitätsklinik Köln, Klinik und Poliklinik für Urologie
Cologne, , 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
Görlitz, , Germany
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Urologie
Hamburg, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Urologie und Kinderurologie
Kiel, , 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
Tübingen, , Germany
Wuppertaler Gemeinschaftspraxis für Dermatologie, Gynäkologie und Urologie
Wuppertal, , Germany
Károlyi Sándor Hospital
Budapest, , Hungary
Semmelweis University
Budapest, , Hungary
Fővárosi Önkormányzat Jahn Ferenc Dél-Pesti Kórház
Budapest, , Hungary
Clinic of Urology
Debrecen, , Hungary
Dombóvári Szt. Lukács Egészségügyi Közhasznú
Dombóvár, , Hungary
Petz Aladár County Hospital
Győr, , Hungary
Kaposi Mór County Hospital
Kaposvár, , Hungary
Nagykanizsa Megyei Jogú Város Hospital
Nagykanizsa, , Hungary
Gróf Esterházy Kórház
Pápa, , Hungary
Dr. Bugyi István Hospital
Szentes, , Hungary
Saint Bobála Hospital
Tatabánya, , Hungary
A.O. Policlinico di Bari, Clinica Urologica I
Bari, , Italy
A.O. Policlinico di Bari, Clinica Urologica
Bari, , Italy
Ospedale S.Annunziata, Unità Operativa di Urologia
Florence, , Italy
Università di Genova Ospedale S. Martino, Reparto Urologia
Genova, , Italy
Ospedale S.Paolo, Cattedra di Urologia
Milan, , 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
Padua, , 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, , Italy
Szpital Bielański, Oddział Urologii
Warsaw, Warszawa, Poland
Klinika Urologii AM w Białymstoku
Bialystok, , Poland
Wojewódzki Szpital Specjalistyczny nr 4
Bytom, , Poland
Gabinet Urologiczny
Gdansk, , Poland
Specjalistyczna Praktyka Lekarska
Katowice, , Poland
Szpital Specjalistyczny Oddzial Urologii
Kościerzyna, , Poland
"Specjalista" Spółka z o. o.
Kutno, , Poland
Wojewódzki Szpital,Oddział i Poradnia Urologiczna
Legnica, , Poland
Szpital Im. Kardynała Stefana Wyszyńskiego, Oddział Urologii
Lublin, , Poland
Katedra i Klinika Urologii Pomorskiej Akademii Medycznej
Szczecin, , Poland
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka, Oddział Urologii
Słupsk, , Poland
Szpital Specjalistyczny, Oddział Urologii
Wejherowo, , Poland
Katedra i Klinika Urologii AM we Wrocławiu
Wroclaw, , Poland
Katedra i Klinika Urologii Śląskiej Akademii Medycznej
Zabrze, , Poland
NZOZ Lekarze Urolodzy, Marek Rozniecki i Partnerzy
Łask, , Poland
Countries
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Other Identifiers
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TH-CR-202
Identifier Type: -
Identifier Source: org_study_id