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

Sponsor

Threshold Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT00435448

Collaborator

PRA Health Sciences (Industry)

480

Enrollment

Locations

Duration (Months)

8.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia Enlarged Prostate	Drug: Lonidamine	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

International prostate symptom score (I-PSS) []

Secondary Outcome Measures

Qmax on uroflowmetry []
Post micturitional residue []
Volume of the prostate []
PSA []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts 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:

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

Contacts and Locations

Locations

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