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

Primary Purpose

Benign Prostatic Hyperplasia, Enlarged Prostate

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lonidamine
Sponsored by
Threshold Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Benign Prostatic Hyperplasia, BPH, Enlarged Prostate

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Vivantes Klinikum am Urban, Klinik für Urologie
  • ClinPharm International GmbH & Co KG--Chemnitz
  • ClinPharm International GmbH & Co KG--Dresden
  • niversitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Urologie
  • Gemeinschaftspraxis Jacobi - Hellmis
  • ClinPharm International GmbH & Co KG--Frankfurt/Main
  • ClinPharm International GmbH & Co KG--Gorlitz
  • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Urologie
  • Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Urologie und Kinderurologie
  • Universitätsklinik Köln, Klinik und Poliklinik für Urologie
  • ClinPharm International GmbH & Co KG--Leipzig
  • ClinPharm International GmbH & Co KG--Magdeburg
  • Urologische Universitätsklinik, Klinikum Mannheim gGmbH, Fakultät für Klinische Medizin Mannheim
  • Klinik für Urologie und Kinderurologie, Klinikum Marburg
  • Klinikum der Universität München, Urologische Klinik und Poliklinik
  • Urologische Klinik und Poliklinik der Technischen Universität München, Klinikum Rechts der Isar
  • Urologische Klinik, Klinikum Landkreis Neumarkt i.d.Obf.
  • Klinik für Urologie, Eberhard-Karls-Universität Tübingen
  • Wuppertaler Gemeinschaftspraxis für Dermatologie, Gynäkologie und Urologie
  • Károlyi Sándor Hospital
  • Semmelweis University
  • Fővárosi Önkormányzat Jahn Ferenc Dél-Pesti Kórház
  • Clinic of Urology
  • Dombóvári Szt. Lukács Egészségügyi Közhasznú
  • Petz Aladár County Hospital
  • Kaposi Mór County Hospital
  • Nagykanizsa Megyei Jogú Város Hospital
  • Gróf Esterházy Kórház
  • Dr. Bugyi István Hospital
  • Saint Bobála Hospital
  • A.O. Policlinico di Bari, Clinica Urologica I
  • A.O. Policlinico di Bari, Clinica Urologica
  • Ospedale S.Annunziata, Unità Operativa di Urologia
  • Università di Genova Ospedale S. Martino, Reparto Urologia
  • Ospedale S.Paolo, Cattedra di Urologia
  • Università Federico II, Clinica Urologica Edificio 5
  • Azienda Ospedaliera S.Luigi di Orbassano, Reparto di urologia universitaria
  • Azienda Ospedaliera, Dipartimento di Urologia
  • A.O. Pliclinico Paolo Giaccone, U.O. Urologia con Litotrissia Extracorporea
  • Azienda Ospedaliera Pisana, Dipartimento di Urologia 1
  • Policlinico Sassarese, Istituto di Clinica Urologica
  • Ospedale Maggiore S.Giovanni Battista, Istituto di Urologia
  • Ospedale S.Giovanni Bosco, Dipartimento di Urologia
  • Klinika Urologii AM w Białymstoku
  • Wojewódzki Szpital Specjalistyczny nr 4
  • Gabinet Urologiczny
  • Specjalistyczna Praktyka Lekarska
  • Szpital Specjalistyczny Oddzial Urologii
  • "Specjalista" Spółka z o. o.
  • Wojewódzki Szpital,Oddział i Poradnia Urologiczna
  • Szpital Im. Kardynała Stefana Wyszyńskiego, Oddział Urologii
  • Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka, Oddział Urologii
  • Katedra i Klinika Urologii Pomorskiej Akademii Medycznej
  • Szpital Bielański, Oddział Urologii
  • Szpital Specjalistyczny, Oddział Urologii
  • Katedra i Klinika Urologii AM we Wrocławiu
  • Katedra i Klinika Urologii Śląskiej Akademii Medycznej
  • NZOZ Lekarze Urolodzy, Marek Rozniecki i Partnerzy

Outcomes

Primary Outcome Measures

International prostate symptom score (I-PSS)

Secondary Outcome Measures

Qmax on uroflowmetry
Post micturitional residue
Volume of the prostate
PSA

Full Information

First Posted
February 8, 2007
Last Updated
April 28, 2009
Sponsor
Threshold Pharmaceuticals
Collaborators
PRA Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00435448
Brief Title
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

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Terminated
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Threshold Pharmaceuticals
Collaborators
PRA Health Sciences

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia, Enlarged Prostate
Keywords
Benign Prostatic Hyperplasia, BPH, Enlarged Prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
480 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lonidamine
Primary Outcome Measure Information:
Title
International prostate symptom score (I-PSS)
Secondary Outcome Measure Information:
Title
Qmax on uroflowmetry
Title
Post micturitional residue
Title
Volume of the prostate
Title
PSA

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Alken, MD
Organizational Affiliation
Fakultät für Klinische Medizin Mannheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vivantes Klinikum am Urban, Klinik für Urologie
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
ClinPharm International GmbH & Co KG--Chemnitz
City
Chemnitz
ZIP/Postal Code
09120
Country
Germany
Facility Name
ClinPharm International GmbH & Co KG--Dresden
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
niversitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Urologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Gemeinschaftspraxis Jacobi - Hellmis
City
Duisburg
ZIP/Postal Code
47179
Country
Germany
Facility Name
ClinPharm International GmbH & Co KG--Frankfurt/Main
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
ClinPharm International GmbH & Co KG--Gorlitz
City
Gorlitz
ZIP/Postal Code
02826
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Urologie
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Urologie und Kinderurologie
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitätsklinik Köln, Klinik und Poliklinik für Urologie
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
ClinPharm International GmbH & Co KG--Leipzig
City
Leipzig
ZIP/Postal Code
04229
Country
Germany
Facility Name
ClinPharm International GmbH & Co KG--Magdeburg
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Urologische Universitätsklinik, Klinikum Mannheim gGmbH, Fakultät für Klinische Medizin Mannheim
City
Mannheim
ZIP/Postal Code
68135
Country
Germany
Facility Name
Klinik für Urologie und Kinderurologie, Klinikum Marburg
City
Marburg
ZIP/Postal Code
35033
Country
Germany
Facility Name
Klinikum der Universität München, Urologische Klinik und Poliklinik
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Urologische Klinik und Poliklinik der Technischen Universität München, Klinikum Rechts der Isar
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Urologische Klinik, Klinikum Landkreis Neumarkt i.d.Obf.
City
Neumarkt
ZIP/Postal Code
92318
Country
Germany
Facility Name
Klinik für Urologie, Eberhard-Karls-Universität Tübingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Wuppertaler Gemeinschaftspraxis für Dermatologie, Gynäkologie und Urologie
City
Wuppertal
ZIP/Postal Code
42103
Country
Germany
Facility Name
Károlyi Sándor Hospital
City
Budapest
ZIP/Postal Code
1047
Country
Hungary
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Fővárosi Önkormányzat Jahn Ferenc Dél-Pesti Kórház
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
Clinic of Urology
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Dombóvári Szt. Lukács Egészségügyi Közhasznú
City
Dombóvár
ZIP/Postal Code
7200
Country
Hungary
Facility Name
Petz Aladár County Hospital
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Kaposi Mór County Hospital
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Nagykanizsa Megyei Jogú Város Hospital
City
Nagykanizsa
ZIP/Postal Code
8800
Country
Hungary
Facility Name
Gróf Esterházy Kórház
City
Papa
ZIP/Postal Code
8500
Country
Hungary
Facility Name
Dr. Bugyi István Hospital
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Saint Bobála Hospital
City
Tatabánya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
A.O. Policlinico di Bari, Clinica Urologica I
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
A.O. Policlinico di Bari, Clinica Urologica
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Ospedale S.Annunziata, Unità Operativa di Urologia
City
Firenze
ZIP/Postal Code
50011
Country
Italy
Facility Name
Università di Genova Ospedale S. Martino, Reparto Urologia
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale S.Paolo, Cattedra di Urologia
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Università Federico II, Clinica Urologica Edificio 5
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera S.Luigi di Orbassano, Reparto di urologia universitaria
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Azienda Ospedaliera, Dipartimento di Urologia
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
A.O. Pliclinico Paolo Giaccone, U.O. Urologia con Litotrissia Extracorporea
City
Palermo
ZIP/Postal Code
90129
Country
Italy
Facility Name
Azienda Ospedaliera Pisana, Dipartimento di Urologia 1
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Policlinico Sassarese, Istituto di Clinica Urologica
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Ospedale Maggiore S.Giovanni Battista, Istituto di Urologia
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale S.Giovanni Bosco, Dipartimento di Urologia
City
Torino
ZIP/Postal Code
10154
Country
Italy
Facility Name
Klinika Urologii AM w Białymstoku
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny nr 4
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Gabinet Urologiczny
City
Gdańsk
ZIP/Postal Code
80-210
Country
Poland
Facility Name
Specjalistyczna Praktyka Lekarska
City
Katowice
ZIP/Postal Code
40-086
Country
Poland
Facility Name
Szpital Specjalistyczny Oddzial Urologii
City
Koscierzyna
ZIP/Postal Code
83-400
Country
Poland
Facility Name
"Specjalista" Spółka z o. o.
City
Kutno
ZIP/Postal Code
99-300
Country
Poland
Facility Name
Wojewódzki Szpital,Oddział i Poradnia Urologiczna
City
Legnica
ZIP/Postal Code
59-220
Country
Poland
Facility Name
Szpital Im. Kardynała Stefana Wyszyńskiego, Oddział Urologii
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka, Oddział Urologii
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Katedra i Klinika Urologii Pomorskiej Akademii Medycznej
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Szpital Bielański, Oddział Urologii
City
Warszawa
ZIP/Postal Code
01-908
Country
Poland
Facility Name
Szpital Specjalistyczny, Oddział Urologii
City
Wejherowo
ZIP/Postal Code
84-200
Country
Poland
Facility Name
Katedra i Klinika Urologii AM we Wrocławiu
City
Wroclaw
ZIP/Postal Code
50-043
Country
Poland
Facility Name
Katedra i Klinika Urologii Śląskiej Akademii Medycznej
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
NZOZ Lekarze Urolodzy, Marek Rozniecki i Partnerzy
City
Łask
ZIP/Postal Code
98-100
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

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

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