Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00435448
• Other study ID #: TH-CR-202
• Status: Terminated
• Phase: Phase 3
• First received: February 8, 2007
• Last updated: April 28, 2009
• Start date: June 2005
• Est. completion date: December 2006

Study information

• Verified date: April 2009
• Source: Threshold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Enlarged Prostate
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Lonidamine

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Threshold Pharmaceuticals	PRA Health Sciences

Countries where clinical trial is conducted

Germany,  Hungary,  Italy,  Poland, 

Outcome

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