Benign Prostatic HyperplasiaPhase 2NCT00237536
Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
A Phase 2 study testing Lonidamine in people with Benign Prostatic Hyperplasia, run by Threshold Pharmaceuticals at 34 sites in United States.
Trial summary
The purpose of this trial is to evaluate the dose response relationship of lonidamine and the primary efficacy endpoint, International Prostate Symptom Score (IPSS), in subjects with symptomatic benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 65 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Lonidamine
- How many people
- 240 participants
- Where
- 34 sitesUnited States
- Study dates
- Jun 2005to Aug 2006
- Phase
- Phase 2
- 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 65 to 80 years
- Men only
- No healthy volunteers
- 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 65-80 years of age (or 40-80 with vasectomy). Vasectomized men must have documentation of azoospermia.
- 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)
- IPSS (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 for the treatment of BPH in the past 2 weeks (alpha-blockers and/or 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
- 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 steroids 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 unacceptable risk to the subject
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Chris B. Threatt, MD Inc.
Atherton, California, 94027
Urology Research Options
Aurora, Colorado, 80012
South Florida Medical Research
Aventura, Florida, 33180
Delaware Valley Clinical Research
Cherry Hill, New Jersey, 08003
Midwest Prostate & Urology Health Center
Chicago, Illinois, 60640
Tampa Bay Medical Research
Clearwater, Florida, 33761
Radiant Research. Columbus
Columbus, Ohio, 43212
Urological Sciences Research Foundation
Culver City, California, 90232
UT Southwestern Medical Center at Dallas, Dept of Urology
Dallas, Texas, 75390
Northeast Indiana research, LLC
Fort Wayne, Indiana, 46825
Accumed Research Associates
Garden City, New York, 11530
Werner, Murdock & Francis, PA, Urology Associates
Greenbelt, Maryland, 20770
Radiant Research, Greer
Greer, South Carolina, 29651
Accelovance
Houston, Texas, 77024
Baylor College of Medicine, Scott Department of Urology
Houston, Texas, 77030
Metropolitan Urology
Jeffersonville, Indiana, 47130
Urological Associates of Lancaster
Lancaster, Pennsylvania, 17604
Sheldon J. Freedman, MD Ltd.
Las Vegas, Nevada, 89109
Lawrenceville Urology
Lawrenceville, New Jersey, 08648
Atlantic Urological Medical Group
Long Beach, California, 90806
Integrity Medical Research, LLC
Mountlake Terrace, Washington, 98043
New York University School of Medicine
New York, New York, 10016
Weill Medical College of Cornell University
New York, New York, 10021
California Professional Research
Newport Beach, California, 92660
Florida Healthcare Research
Ocala, Florida, 34474
Specialty Care Research
Peoria, Illinois, 61614
University Urological Research Institute
Providence, Rhode Island, 02904
Urology San Antonio Research
San Antonio, Texas, 78229
San Diego Uro-Research
San Diego, California, 92103
Stanford University Hospital
Stanford, California, 94305
State College Urologic Associates
State College, Pennsylvania, 16801
Advanced Clinical Therapeutics
Tucson, Arizona, 85712
Connecticut Clinical Research Center Urology Specialists
Waterbury, Connecticut, 06708
Urology Healthcare Associates
Woodlane, New Jersey, 08060
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose Comparison Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
The purpose of this trial is to evaluate the dose response relationship of lonidamine and the primary efficacy endpoint, International Prostate Symptom Score (IPSS), in subjects with symptomatic benign prostatic hyperplasia (BPH).
- Conditions
- Benign Prostatic Hyperplasia
- 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.
IPSS
Secondary outcomes (4)
Maximum urinary flow rate (Qmax)
Post-void residual urine volume (PVR)
Prostate volume
Prostate specific antigen (PSA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startJun 2005
- Primary completionAug 2006
- Study completionAug 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Threshold Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237536
- Sponsor's protocol ID
- TH-CR-203
- Status last verified
- Apr 2009
- First submitted
- 10 Oct 2005
- 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, Double-Blind, Placebo-Controlled, Dose Comparison Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT00237536
- Acronym / sponsor ID
- TH-CR-203
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign Prostatic Hyperplasia, BPH, Enlarged Prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 240 participants
- Lead sponsor
- Threshold PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 12 Oct 2005 (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 trial is to evaluate the dose response relationship of lonidamine and the primary efficacy endpoint, International Prostate Symptom Score (IPSS), in subjects with symptomatic benign prostatic hyperplasia (BPH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- 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 65-80 years of age (or 40-80 with vasectomy). Vasectomized men must have documentation of azoospermia.
- 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 for the treatment of BPH in the past 2 weeks (alpha-blockers and/or 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
IPSS
4 secondary outcomes
Maximum urinary flow rate (Qmax)
Post-void residual urine volume (PVR)
Prostate volume
Prostate specific antigen (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.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lonidamine in people with Benign Prostatic Hyperplasia, run by Threshold Pharmaceuticals at 34 sites in United States.
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 34 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
IPSS. 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.