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

April 28, 2009 updated by: Threshold Pharmaceuticals

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10967
        • Vivantes Klinikum am Urban, Klinik für Urologie
      • Chemnitz, Germany, 09120
        • ClinPharm International GmbH & Co KG--Chemnitz
      • Dresden, Germany, 01067
        • ClinPharm International GmbH & Co KG--Dresden
      • Dresden, Germany, 01307
        • niversitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Urologie
      • Duisburg, Germany, 47179
        • Gemeinschaftspraxis Jacobi - Hellmis
      • Frankfurt, Germany, 60596
        • ClinPharm International GmbH & Co KG--Frankfurt/Main
      • Gorlitz, Germany, 02826
        • ClinPharm International GmbH & Co KG--Gorlitz
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Urologie
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Urologie und Kinderurologie
      • Köln, Germany, 50924
        • Universitätsklinik Köln, Klinik und Poliklinik für Urologie
      • Leipzig, Germany, 04229
        • ClinPharm International GmbH & Co KG--Leipzig
      • Magdeburg, Germany, 39104
        • ClinPharm International GmbH & Co KG--Magdeburg
      • Mannheim, Germany, 68135
        • Urologische Universitätsklinik, Klinikum Mannheim gGmbH, Fakultät für Klinische Medizin Mannheim
      • Marburg, Germany, 35033
        • Klinik für Urologie und Kinderurologie, Klinikum Marburg
      • München, Germany, 81377
        • Klinikum der Universität München, Urologische Klinik und Poliklinik
      • München, Germany, 81675
        • Urologische Klinik und Poliklinik der Technischen Universität München, Klinikum Rechts der Isar
      • Neumarkt, Germany, 92318
        • Urologische Klinik, Klinikum Landkreis Neumarkt i.d.Obf.
      • Tubingen, Germany, 72076
        • Klinik für Urologie, Eberhard-Karls-Universität Tübingen
      • Wuppertal, Germany, 42103
        • Wuppertaler Gemeinschaftspraxis für Dermatologie, Gynäkologie und Urologie
  • Hungary
      • Budapest, Hungary, 1082
        • Semmelweis University
      • Budapest, Hungary, 1047
        • Károlyi Sándor Hospital
      • Budapest, Hungary, 1204
        • Fővárosi Önkormányzat Jahn Ferenc Dél-Pesti Kórház
      • Debrecen, Hungary, 4012
        • Clinic of Urology
      • Dombóvár, Hungary, 7200
        • Dombóvári Szt. Lukács Egészségügyi Közhasznú
      • Gyor, Hungary, 9024
        • Petz Aladar County Hospital
      • Kaposvar, Hungary, 7400
        • Kaposi Mór County Hospital
      • Nagykanizsa, Hungary, 8800
        • Nagykanizsa Megyei Jogú Város Hospital
      • Papa, Hungary, 8500
        • Gróf Esterházy Kórház
      • Szentes, Hungary, 6600
        • Dr. Bugyi István Hospital
      • Tatabánya, Hungary, 2800
        • Saint Bobála Hospital
  • Italy
      • Bari, Italy, 70124
        • A.O. Policlinico di Bari, Clinica Urologica I
      • Bari, Italy, 70124
        • A.O. Policlinico di Bari, Clinica Urologica
      • Firenze, Italy, 50011
        • Ospedale S.Annunziata, Unità Operativa di Urologia
      • Genova, Italy, 16132
        • Università di Genova Ospedale S. Martino, Reparto Urologia
      • Milano, Italy, 20142
        • Ospedale S.Paolo, Cattedra di Urologia
      • Napoli, Italy, 80131
        • Università Federico II, Clinica Urologica Edificio 5
      • Orbassano, Italy, 10043
        • Azienda Ospedaliera S.Luigi di Orbassano, Reparto di urologia universitaria
      • Padova, Italy, 35128
        • Azienda Ospedaliera, Dipartimento di Urologia
      • Palermo, Italy, 90129
        • A.O. Pliclinico Paolo Giaccone, U.O. Urologia con Litotrissia Extracorporea
      • Pisa, Italy, 56126
        • Azienda Ospedaliera Pisana, Dipartimento di Urologia 1
      • Sassari, Italy, 07100
        • Policlinico Sassarese, Istituto di Clinica Urologica
      • Torino, Italy, 10126
        • Ospedale Maggiore S.Giovanni Battista, Istituto di Urologia
      • Torino, Italy, 10154
        • Ospedale S.Giovanni Bosco, Dipartimento di Urologia
  • Poland
      • Bialystok, Poland, 15-276
        • Klinika Urologii AM w Białymstoku
      • Bytom, Poland, 41-902
        • Wojewódzki Szpital Specjalistyczny nr 4
      • Gdańsk, Poland, 80-210
        • Gabinet Urologiczny
      • Katowice, Poland, 40-086
        • Specjalistyczna Praktyka Lekarska
      • Koscierzyna, Poland, 83-400
        • Szpital Specjalistyczny Oddzial Urologii
      • Kutno, Poland, 99-300
        • "Specjalista" Spółka z o. o.
      • Legnica, Poland, 59-220
        • Wojewódzki Szpital,Oddział i Poradnia Urologiczna
      • Lublin, Poland, 20-718
        • Szpital Im. Kardynała Stefana Wyszyńskiego, Oddział Urologii
      • Slupsk, Poland, 76-200
        • Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka, Oddział Urologii
      • Szczecin, Poland, 70-111
        • Katedra i Klinika Urologii Pomorskiej Akademii Medycznej
      • Warszawa, Poland, 01-908
        • Szpital Bielański, Oddział Urologii
      • Wejherowo, Poland, 84-200
        • Szpital Specjalistyczny, Oddział Urologii
      • Wroclaw, Poland, 50-043
        • Katedra i Klinika Urologii AM we Wrocławiu
      • Zabrze, Poland, 41-800
        • Katedra i Klinika Urologii Śląskiej Akademii Medycznej
      • Łask, Poland, 98-100
        • NZOZ Lekarze Urolodzy, Marek Rozniecki i Partnerzy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
International prostate symptom score (I-PSS)

Secondary Outcome Measures

Outcome Measure
PSA
Qmax on uroflowmetry
Post micturitional residue
Volume of the prostate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Threshold Pharmaceuticals

Collaborators

PRA Health Sciences

Investigators

  • Principal Investigator: Peter Alken, MD, Fakultät für Klinische Medizin Mannheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

February 8, 2007

First Submitted That Met QC Criteria

February 14, 2007

First Posted (Estimate)

February 15, 2007

Study Record Updates

Last Update Posted (Estimate)

April 29, 2009

Last Update Submitted That Met QC Criteria

April 28, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TH-CR-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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