Clinical trial NCT00435448: Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Enlarged Prostate
Keywords: Benign Prostatic Hyperplasia
BPH
Enlarged Prostate
Lead sponsor: Threshold Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2007-02-15
Enrollment: 480
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of lonidamine (50mg, 150mg) compared to placebo in subjects with symptomatic BPH.


Eligibility criteria: 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

Primary outcomes:
measure: International prostate symptom score (I-PSS)
Secondary outcomes:
measure: Qmax on uroflowmetry
measure: Post micturitional residue
measure: Volume of the prostate
measure: PSA
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Vivantes Klinikum am Urban, Klinik für Urologie
city: Chemnitz
country: Germany
facility: ClinPharm International GmbH & Co KG--Chemnitz
city: Dresden
country: Germany
facility: ClinPharm International GmbH & Co KG--Dresden
city: Dresden
country: Germany
facility: niversitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Urologie
city: Duisburg
country: Germany
facility: Gemeinschaftspraxis Jacobi - Hellmis
city: Frankfurt
country: Germany
facility: ClinPharm International GmbH & Co KG--Frankfurt/Main
city: Gorlitz
country: Germany
facility: ClinPharm International GmbH & Co KG--Gorlitz
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Urologie
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Urologie und Kinderurologie
city: Köln
country: Germany
facility: Universitätsklinik Köln, Klinik und Poliklinik für Urologie
city: Leipzig
country: Germany
facility: ClinPharm International GmbH & Co KG--Leipzig
city: Magdeburg
country: Germany
facility: ClinPharm International GmbH & Co KG--Magdeburg
city: Mannheim
country: Germany
facility: Urologische Universitätsklinik, Klinikum Mannheim gGmbH, Fakultät für Klinische Medizin Mannheim
city: Marburg
country: Germany
facility: Klinik für Urologie und Kinderurologie, Klinikum Marburg
city: München
country: Germany
facility: Klinikum der Universität München, Urologische Klinik und Poliklinik
city: München
country: Germany
facility: Urologische Klinik und Poliklinik der Technischen Universität München, Klinikum Rechts der Isar
city: Neumarkt
country: Germany
facility: Urologische Klinik, Klinikum Landkreis Neumarkt i.d.Obf.
city: Tubingen
country: Germany
facility: Klinik für Urologie, Eberhard-Karls-Universität Tübingen
city: Wuppertal
country: Germany
facility: Wuppertaler Gemeinschaftspraxis für Dermatologie, Gynäkologie und Urologie
city: Budapest
country: Hungary
facility: Károlyi Sándor Hospital
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: Fővárosi Önkormányzat Jahn Ferenc Dél-Pesti Kórház
city: Debrecen
country: Hungary
facility: Clinic of Urology
city: Dombóvár
country: Hungary
facility: Dombóvári Szt. Lukács Egészségügyi Közhasznú
city: Gyor
country: Hungary
facility: Petz Aladár County Hospital
city: Kaposvar
country: Hungary
facility: Kaposi Mór County Hospital
city: Nagykanizsa
country: Hungary
facility: Nagykanizsa Megyei Jogú Város Hospital
city: Papa
country: Hungary
facility: Gróf Esterházy Kórház
city: Szentes
country: Hungary
facility: Dr. Bugyi István Hospital
city: Tatabánya
country: Hungary
facility: Saint Bobála Hospital
city: Bari
country: Italy
facility: A.O. Policlinico di Bari, Clinica Urologica I
city: Bari
country: Italy
facility: A.O. Policlinico di Bari, Clinica Urologica
city: Firenze
country: Italy
facility: Ospedale S.Annunziata, Unità Operativa di Urologia
city: Genova
country: Italy
facility: Università di Genova Ospedale S. Martino, Reparto Urologia
city: Milano
country: Italy
facility: Ospedale S.Paolo, Cattedra di Urologia
city: Napoli
country: Italy
facility: Università Federico II, Clinica Urologica Edificio 5
city: Orbassano
country: Italy
facility: Azienda Ospedaliera S.Luigi di Orbassano, Reparto di urologia universitaria
city: Padova
country: Italy
facility: Azienda Ospedaliera, Dipartimento di Urologia
city: Palermo
country: Italy
facility: A.O. Pliclinico Paolo Giaccone, U.O. Urologia con Litotrissia Extracorporea
city: Pisa
country: Italy
facility: Azienda Ospedaliera Pisana, Dipartimento di Urologia 1
city: Sassari
country: Italy
facility: Policlinico Sassarese, Istituto di Clinica Urologica
city: Torino
country: Italy
facility: Ospedale Maggiore S.Giovanni Battista, Istituto di Urologia
city: Torino
country: Italy
facility: Ospedale S.Giovanni Bosco, Dipartimento di Urologia
city: Bialystok
country: Poland
facility: Klinika Urologii AM w Białymstoku
city: Bytom
country: Poland
facility: Wojewódzki Szpital Specjalistyczny nr 4
city: Gdańsk
country: Poland
facility: Gabinet Urologiczny
city: Katowice
country: Poland
facility: Specjalistyczna Praktyka Lekarska
city: Koscierzyna
country: Poland
facility: Szpital Specjalistyczny Oddzial Urologii
city: Kutno
country: Poland
facility: "Specjalista" Spółka z o. o.
city: Legnica
country: Poland
facility: Wojewódzki Szpital,Oddział i Poradnia Urologiczna
city: Lublin
country: Poland
facility: Szpital Im. Kardynała Stefana Wyszyńskiego, Oddział Urologii
city: Slupsk
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka, Oddział Urologii
city: Szczecin
country: Poland
facility: Katedra i Klinika Urologii Pomorskiej Akademii Medycznej
city: Warszawa
country: Poland
facility: Szpital Bielański, Oddział Urologii
city: Wejherowo
country: Poland
facility: Szpital Specjalistyczny, Oddział Urologii
city: Wroclaw
country: Poland
facility: Katedra i Klinika Urologii AM we Wrocławiu
city: Zabrze
country: Poland
facility: Katedra i Klinika Urologii Śląskiej Akademii Medycznej
city: Łask
country: Poland
facility: NZOZ Lekarze Urolodzy, Marek Rozniecki i Partnerzy
Study officials:
affiliation: Fakultät für Klinische Medizin Mannheim
name: Peter Alken, MD
role: PRINCIPAL_INVESTIGATOR
References: