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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: December 6, 2006
Last updated: November 12, 2010
Last verified: November 2010
This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.

Condition Intervention Phase
Prostatic Hyperplasia Drug: UK-369,003 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Maximum flow rate (Qmax) [ Time Frame: Duration of study ]
  • Cystometric capacity [ Time Frame: Duration of study ]
  • Post void residual volume (PVR) [ Time Frame: Duration of study ]
  • Average flow rate (Qave) [ Time Frame: Duration of study ]
  • Volume at first unstable contraction [ Time Frame: Duration of study ]
  • Average detrusor pressure during micturition [ Time Frame: Duration of study ]
  • Detrusor pressure at maximum flow rate (PdetQmax) [ Time Frame: Duration of study ]
  • Bladder outlet obstruction index (BOOI) [ Time Frame: Duration of study ]
  • Bladder contractility index (BCI) [ Time Frame: Duration of study ]
  • Bladder voiding efficiency (BE) [ Time Frame: Duration of study ]
  • Frequency of unstable contractions [ Time Frame: Duration of study ]
  • International Prostate Symptom Score (IPSS) [ Time Frame: Duration of study ]
  • Mean amplitude of unstable contractions [ Time Frame: Duration of study ]
  • Patient Reported Treatment Impact (PRTI) [ Time Frame: Duration of study ]

Enrollment: 27
Study Start Date: March 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: UK-369,003
UK-369,003-100 mg MR formulation for 2 weeks
Active Comparator: UK-369,003 Drug: UK-369,003
100 mg MR tablet once daily for 2 weeks


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00408954

Czech Republic
Pfizer Investigational Site
Brno, Czech Republic, 612 00
Pfizer Investigational Site
Hradec Kralove, Czech Republic, 500 02
Pfizer Investigational Site
Olomouc, Czech Republic, 775 20
Pfizer Investigational Site
Usti nad Labem, Czech Republic, 401 13
Pfizer Investigational Site
Amsterdam, Netherlands, 1081 HV
Pfizer Investigational Site
Nijmegen, Netherlands, 6525 GA
Pfizer Investigational Site
Bratislava, Slovakia, 833 05
Pfizer Investigational Site
Kosice, Slovakia, 040 11
Pfizer Investigational Site
Kosice, Slovakia, 041 90
Pfizer Investigational Site
Martin, Slovakia, 036 59
Pfizer Investigational Site
Trencin, Slovakia, 911 01
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00408954     History of Changes
Other Study ID Numbers: A3711045
Study First Received: December 6, 2006
Last Updated: November 12, 2010

Additional relevant MeSH terms:
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms processed this record on September 21, 2017