Benign Prostatic HyperplasiaPhase 3NCT00435448
Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
A Phase 3 study testing Lonidamine in people with Benign Prostatic Hyperplasia and Enlarged Prostate, run by Threshold Pharmaceuticals at 58 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the efficacy of lonidamine (50mg, 150mg) compared to placebo in subjects with symptomatic BPH. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Enlarged Prostate
- What is being tested?
- Lonidamine
- How many people
- 480 participants
- Where
- 58 sitesin 4 countries
- Study dates
- Jun 2005to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
58 sites in 4 countries.
58 sites in 4 countries
Germany19 sites
Vivantes Klinikum am Urban, Klinik für Urologie
Berlin, 10967
ClinPharm International GmbH & Co KG--Chemnitz
Chemnitz, 09120
Universitätsklinik Köln, Klinik und Poliklinik für Urologie
Cologne, 50924
ClinPharm International GmbH & Co KG--Dresden
Dresden, 01067
niversitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Urologie
Dresden, 01307
Gemeinschaftspraxis Jacobi - Hellmis
Duisburg, 47179
ClinPharm International GmbH & Co KG--Frankfurt/Main
Frankfurt, 60596
ClinPharm International GmbH & Co KG--Gorlitz
Görlitz, 02826
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Urologie
Hamburg, 20246
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Urologie und Kinderurologie
Kiel, 24105
ClinPharm International GmbH & Co KG--Leipzig
Leipzig, 04229
ClinPharm International GmbH & Co KG--Magdeburg
Magdeburg, 39104
Urologische Universitätsklinik, Klinikum Mannheim gGmbH, Fakultät für Klinische Medizin Mannheim
Mannheim, 68135
Klinik für Urologie und Kinderurologie, Klinikum Marburg
Marburg, 35033
Klinikum der Universität München, Urologische Klinik und Poliklinik
München, 81377
Urologische Klinik und Poliklinik der Technischen Universität München, Klinikum Rechts der Isar
München, 81675
Urologische Klinik, Klinikum Landkreis Neumarkt i.d.Obf.
Neumarkt, 92318
Klinik für Urologie, Eberhard-Karls-Universität Tübingen
Tübingen, 72076
Wuppertaler Gemeinschaftspraxis für Dermatologie, Gynäkologie und Urologie
Wuppertal, 42103
Poland15 sites
Klinika Urologii AM w Białymstoku
Bialystok, 15-276
Wojewódzki Szpital Specjalistyczny nr 4
Bytom, 41-902
Gabinet Urologiczny
Gdansk, 80-210
Specjalistyczna Praktyka Lekarska
Katowice, 40-086
Szpital Specjalistyczny Oddzial Urologii
Kościerzyna, 83-400
"Specjalista" Spółka z o. o.
Kutno, 99-300
NZOZ Lekarze Urolodzy, Marek Rozniecki i Partnerzy
Łask, 98-100
Wojewódzki Szpital,Oddział i Poradnia Urologiczna
Legnica, 59-220
Szpital Im. Kardynała Stefana Wyszyńskiego, Oddział Urologii
Lublin, 20-718
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka, Oddział Urologii
Słupsk, 76-200
Katedra i Klinika Urologii Pomorskiej Akademii Medycznej
Szczecin, 70-111
Szpital Bielański, Oddział Urologii
Warsaw, Warszawa, 01-908
Szpital Specjalistyczny, Oddział Urologii
Wejherowo, 84-200
Katedra i Klinika Urologii AM we Wrocławiu
Wroclaw, 50-043
Katedra i Klinika Urologii Śląskiej Akademii Medycznej
Zabrze, 41-800
Italy13 sites
A.O. Policlinico di Bari, Clinica Urologica I
Bari, 70124
A.O. Policlinico di Bari, Clinica Urologica
Bari, 70124
Ospedale S.Annunziata, Unità Operativa di Urologia
Florence, 50011
Università di Genova Ospedale S. Martino, Reparto Urologia
Genova, 16132
Ospedale S.Paolo, Cattedra di Urologia
Milan, 20142
Università Federico II, Clinica Urologica Edificio 5
Naples, 80131
Azienda Ospedaliera S.Luigi di Orbassano, Reparto di urologia universitaria
Orbassano, 10043
Azienda Ospedaliera, Dipartimento di Urologia
Padova, 35128
A.O. Pliclinico Paolo Giaccone, U.O. Urologia con Litotrissia Extracorporea
Palermo, 90129
Azienda Ospedaliera Pisana, Dipartimento di Urologia 1
Pisa, 56126
Policlinico Sassarese, Istituto di Clinica Urologica
Sassari, 07100
Ospedale Maggiore S.Giovanni Battista, Istituto di Urologia
Torino, 10126
Ospedale S.Giovanni Bosco, Dipartimento di Urologia
Torino, 10154
Hungary11 sites
Károlyi Sándor Hospital
Budapest, 1047
Semmelweis University
Budapest, 1082
Fővárosi Önkormányzat Jahn Ferenc Dél-Pesti Kórház
Budapest, 1204
Clinic of Urology
Debrecen, 4012
Dombóvári Szt. Lukács Egészségügyi Közhasznú
Dombóvár, 7200
Petz Aladár County Hospital
Győr, 9024
Kaposi Mór County Hospital
Kaposvár, 7400
Nagykanizsa Megyei Jogú Város Hospital
Nagykanizsa, 8800
Gróf Esterházy Kórház
Pápa, 8500
Dr. Bugyi István Hospital
Szentes, 6600
Saint Bobála Hospital
Tatabánya, 2800
About this study
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
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
- Being tested
- Lonidamine
- Keywords
- Benign Prostatic Hyperplasia, BPH, Enlarged Prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LonidamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
International prostate symptom score (I-PSS)
Secondary outcomes (4)
Qmax on uroflowmetry
Post micturitional residue
Volume of the prostate
PSA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2007 (estimated)
- Study startJun 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 480 participants
Sponsor and investigators
- Lead sponsor
- Threshold Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Investigators
- Peter Alken, MD, Principal investigator, Fakultät für Klinische Medizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435448
- Sponsor's protocol ID
- TH-CR-202
- Status last verified
- Apr 2009
- First submitted
- 8 Feb 2007
- Last updated
- 29 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00435448
- Acronym / sponsor ID
- TH-CR-202
- Conditions
- Benign Prostatic Hyperplasia, Enlarged Prostate
- Keywords
- Benign Prostatic Hyperplasia, BPH, Enlarged Prostate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 480 participants
- Lead sponsor
- Threshold PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- Jun 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 15 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of lonidamine (50mg, 150mg) compared to placebo in subjects with symptomatic BPH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lonidamine | Drug | – |
Primary outcome
International prostate symptom score (I-PSS)
4 secondary outcomes
Qmax on uroflowmetry
Post micturitional residue
Volume of the prostate
PSA
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Alken, MD principal investigator
Fakultät für Klinische Medizin Mannheim
58 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lonidamine in people with Benign Prostatic Hyperplasia and Enlarged Prostate, run by Threshold Pharmaceuticals at 58 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in Germany, Poland, Italy, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International prostate symptom score (I-PSS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2009.