Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004110

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00004110
  •   2012/10/08
  •   2007/02/08
  •   no
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Secondary IDs

  •   NCT00435448  (ClinicalTrials.gov)
  •   TH-CR-202  (Threshold Pharmaceuticals)
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Health Condition or Problem studied

  •   Benign Prostatic Hyperplasia
  •   Enlarged Prostate
  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   Drug: Lonidamine
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
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  •   Placebo
  •   Treatment
  •   Factorial
  •   III
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Primary Outcome

- International prostate symptom score (I-PSS)

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Secondary Outcome

- Qmax on uroflowmetry
- Post micturitional residue
- Volume of the prostate
- PSA

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Countries of Recruitment

  •   Germany
  •   Hungary
  •   Italy
  •   Poland
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Locations of Recruitment

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Recruitment

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  •   2005/06/30
  •   480
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   50   Years
  •   80   Years
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Additional 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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Threshold Pharmaceuticals
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    • PRA Health Sciences
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    • Fakultät für Klinische Medizin Mannheim
    • Peter Alken, MD 
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    • Fakultät für Klinische Medizin Mannheim
    • Peter Alken, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting stopped after recruiting started
  •   2006/12/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.