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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00408954
First received: December 6, 2006
Last updated: November 12, 2010
Last verified: November 2010

December 6, 2006
November 12, 2010
March 2007
June 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00408954 on ClinicalTrials.gov Archive Site
  • Maximum flow rate (Qmax) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Cystometric capacity [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Post void residual volume (PVR) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Average flow rate (Qave) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Volume at first unstable contraction [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Average detrusor pressure during micturition [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Detrusor pressure at maximum flow rate (PdetQmax) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Bladder outlet obstruction index (BOOI) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Bladder contractility index (BCI) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Bladder voiding efficiency (BE) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Frequency of unstable contractions [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • International Prostate Symptom Score (IPSS) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Mean amplitude of unstable contractions [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • Patient Reported Treatment Impact (PRTI) [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  • There are no specific secondary endpoints for this study as it is not powered
  • for that. The following are the endpoints:1. PdetQmax (detrusor pressure at
  • maximum flow rate). 2. Qmax. 3. Cystometric capacity. 4.Post-void residual urine
  • volume (PVR). 5.Qave (average flow rate) 6.Volume at first unstable
  • contraction. 7.Average detrusor pressure during micturition. 8.BOOI (bladder
  • outlet obstruction index; formerly the Abrams-Griffiths number) 9.BCI (bladder
  • contractility index). 10.BE (Bladder voiding efficiency). 11.Frequency of
  • unstable contraction. 12. Mean amplitude of unstable contractions
  • 13. Patient Reported Treatment Impact (PRTI). 14. International Prostate Symptom
  • Score (IPSS).
Not Provided
Not Provided
 
Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms
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.

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Prostatic Hyperplasia
  • Drug: UK-369,003
    100 mg MR tablet once daily for 2 weeks
  • Drug: UK-369,003
    UK-369,003-100 mg MR formulation for 2 weeks
  • Placebo Comparator: Placebo
    Intervention: Drug: UK-369,003
  • Active Comparator: UK-369,003
    Intervention: Drug: UK-369,003
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Male
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Netherlands,   Slovakia
 
NCT00408954
A3711045
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP