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NCT Number: NCT00408954

Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms

This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Brno, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male subjects, aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13.
  • Clinical diagnosis of BPH
  • Qmax 5 to 15 ml/sec with a voided volume of ≥150 ml
  • Urodynamically defined bladder outlet obstruction

Exclusion criteria

  • prostate cancer
  • Post-void residual urine volume >200 ml
  • Documented UTI
  • History of relevant urological surgery

Treatment and study plan

UK-369,003

Drug

100 mg MR tablet once daily for 2 weeks

Primary outcomes

  1. There is no specific primary endpoint for this study as it is not powered for that. It is mainly to generate hypotheses on the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.

    Time frame: Duration of study

Secondary outcomes

  1. Maximum flow rate (Qmax)

    Time frame: Duration of study

  2. Cystometric capacity

    Time frame: Duration of study

  3. Post void residual volume (PVR)

    Time frame: Duration of study

  4. Average flow rate (Qave)

    Time frame: Duration of study

  5. Volume at first unstable contraction

    Time frame: Duration of study

  6. Average detrusor pressure during micturition

    Time frame: Duration of study

  7. Detrusor pressure at maximum flow rate (PdetQmax)

    Time frame: Duration of study

  8. Bladder outlet obstruction index (BOOI)

    Time frame: Duration of study

  9. Bladder contractility index (BCI)

    Time frame: Duration of study

  10. Bladder voiding efficiency (BE)

    Time frame: Duration of study

  11. Frequency of unstable contractions

    Time frame: Duration of study

  12. International Prostate Symptom Score (IPSS)

    Time frame: Duration of study

  13. Mean amplitude of unstable contractions

    Time frame: Duration of study

  14. Patient Reported Treatment Impact (PRTI)

    Time frame: Duration of study

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Multi Center Randomized Cross Over Double Blind Third Party Open Placebo Controlled Pilot Study to Assess the Urodynamic Effects of Modified Release UK-369,003 in Men With Lower Urinary Tract Symptoms.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 8, 2006
Registry last updated
Nov 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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