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

NCT00435448 | Terminated Phase 3

• 1 other identifier: TH-CR-202
• Study Type: interventional
• Target: 480
• Locations: 4 countries
• Sites: 58

Brief Summary

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

Conditions

Benign Prostatic Hyperplasia; Enlarged Prostate

Keywords

Benign Prostatic Hyperplasia; BPH; Enlarged Prostate

Outcome Measures

Primary Outcomes (1)

• International prostate symptom score (I-PSS)

Secondary Outcomes (4)

• Qmax on uroflowmetry

• Post micturitional residue

• Volume of the prostate

• PSA

Interventions

Lonidamine DRUG

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Serum creatinine \> 1.8 mg/dL
• ALT or AST \> 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
• 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

Sponsors & Collaborators

• Threshold Pharmaceuticals: lead
• PRA Health Sciences: collaborator

Study Sites (58)

Vivantes Klinikum am Urban, Klinik für Urologie

Berlin, 10967, Germany

Location

ClinPharm International GmbH & Co KG--Chemnitz

Chemnitz, 09120, Germany

Location

Universitätsklinik Köln, Klinik und Poliklinik für Urologie

Cologne, 50924, Germany

Location

ClinPharm International GmbH & Co KG--Dresden

Dresden, 01067, Germany

Location

niversitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Urologie

Dresden, 01307, Germany

Location

Gemeinschaftspraxis Jacobi - Hellmis

Duisburg, 47179, Germany

Location

ClinPharm International GmbH & Co KG--Frankfurt/Main

Frankfurt, 60596, Germany

Location

ClinPharm International GmbH & Co KG--Gorlitz

Görlitz, 02826, Germany

Location

Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Urologie

Hamburg, 20246, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Urologie und Kinderurologie

Kiel, 24105, Germany

Location

ClinPharm International GmbH & Co KG--Leipzig

Leipzig, 04229, Germany

Location

ClinPharm International GmbH & Co KG--Magdeburg

Magdeburg, 39104, Germany

Location

Urologische Universitätsklinik, Klinikum Mannheim gGmbH, Fakultät für Klinische Medizin Mannheim

Mannheim, 68135, Germany

Location

Klinik für Urologie und Kinderurologie, Klinikum Marburg

Marburg, 35033, Germany

Location

Klinikum der Universität München, Urologische Klinik und Poliklinik

München, 81377, Germany

Location

Urologische Klinik und Poliklinik der Technischen Universität München, Klinikum Rechts der Isar

München, 81675, Germany

Location

Urologische Klinik, Klinikum Landkreis Neumarkt i.d.Obf.

Neumarkt, 92318, Germany

Location

Klinik für Urologie, Eberhard-Karls-Universität Tübingen

Tübingen, 72076, Germany

Location

Wuppertaler Gemeinschaftspraxis für Dermatologie, Gynäkologie und Urologie

Wuppertal, 42103, Germany

Location

Károlyi Sándor Hospital

Budapest, 1047, Hungary

Location

Semmelweis University

Budapest, 1082, Hungary

Location

Fővárosi Önkormányzat Jahn Ferenc Dél-Pesti Kórház

Budapest, 1204, Hungary

Location

Clinic of Urology

Debrecen, 4012, Hungary

Location

Dombóvári Szt. Lukács Egészségügyi Közhasznú

Dombóvár, 7200, Hungary

Location

Petz Aladár County Hospital

Győr, 9024, Hungary

Location

Kaposi Mór County Hospital

Kaposvár, 7400, Hungary

Location

Nagykanizsa Megyei Jogú Város Hospital

Nagykanizsa, 8800, Hungary

Location

Gróf Esterházy Kórház

Pápa, 8500, Hungary

Location

Dr. Bugyi István Hospital

Szentes, 6600, Hungary

Location

Saint Bobála Hospital

Tatabánya, 2800, Hungary

Location

A.O. Policlinico di Bari, Clinica Urologica I

Bari, 70124, Italy

Location

A.O. Policlinico di Bari, Clinica Urologica

Bari, 70124, Italy

Location

Ospedale S.Annunziata, Unità Operativa di Urologia

Florence, 50011, Italy

Location

Università di Genova Ospedale S. Martino, Reparto Urologia

Genova, 16132, Italy

Location

Ospedale S.Paolo, Cattedra di Urologia

Milan, 20142, Italy

Location

Università Federico II, Clinica Urologica Edificio 5

Napoli, 80131, Italy

Location

Azienda Ospedaliera S.Luigi di Orbassano, Reparto di urologia universitaria

Orbassano, 10043, Italy

Location

Azienda Ospedaliera, Dipartimento di Urologia

Padua, 35128, Italy

Location

A.O. Pliclinico Paolo Giaccone, U.O. Urologia con Litotrissia Extracorporea

Palermo, 90129, Italy

Location

Azienda Ospedaliera Pisana, Dipartimento di Urologia 1

Pisa, 56126, Italy

Location

Policlinico Sassarese, Istituto di Clinica Urologica

Sassari, 07100, Italy

Location

Ospedale Maggiore S.Giovanni Battista, Istituto di Urologia

Torino, 10126, Italy

Location

Ospedale S.Giovanni Bosco, Dipartimento di Urologia

Torino, 10154, Italy

Location

Szpital Bielański, Oddział Urologii

Warsaw, Warszawa, 01-908, Poland

Location

Klinika Urologii AM w Białymstoku

Bialystok, 15-276, Poland

Location

Wojewódzki Szpital Specjalistyczny nr 4

Bytom, 41-902, Poland

Location

Gabinet Urologiczny

Gdansk, 80-210, Poland

Location

Specjalistyczna Praktyka Lekarska

Katowice, 40-086, Poland

Location

Szpital Specjalistyczny Oddzial Urologii

Kościerzyna, 83-400, Poland

Location

"Specjalista" Spółka z o. o.

Kutno, 99-300, Poland

Location

Wojewódzki Szpital,Oddział i Poradnia Urologiczna

Legnica, 59-220, Poland

Location

Szpital Im. Kardynała Stefana Wyszyńskiego, Oddział Urologii

Lublin, 20-718, Poland

Location

Katedra i Klinika Urologii Pomorskiej Akademii Medycznej

Szczecin, 70-111, Poland

Location

Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka, Oddział Urologii

Słupsk, 76-200, Poland

Location

Szpital Specjalistyczny, Oddział Urologii

Wejherowo, 84-200, Poland

Location

Katedra i Klinika Urologii AM we Wrocławiu

Wroclaw, 50-043, Poland

Location

Katedra i Klinika Urologii Śląskiej Akademii Medycznej

Zabrze, 41-800, Poland

Location

NZOZ Lekarze Urolodzy, Marek Rozniecki i Partnerzy

Łask, 98-100, Poland

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

lonidamine

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Peter Alken, MD

  Fakultät für Klinische Medizin Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 8, 2007
• First Posted: February 15, 2007
• Study Start: June 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: April 29, 2009

Record last verified: 2009-04

Locations

IT (13); HU (11); PL (15); DE (19)