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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00408954
Recruitment Status : Completed
First Posted : December 8, 2006
Last Update Posted : November 23, 2010
Sponsor:
Information provided by:
Pfizer

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

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Drug: UK-369,003 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
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.
Study Start Date : March 2007
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408954


Locations
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
Netherlands
Pfizer Investigational Site
Amsterdam, Netherlands, 1081 HV
Pfizer Investigational Site
Nijmegen, Netherlands, 6525 GA
Slovakia
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00408954     History of Changes
Other Study ID Numbers: A3711045
First Posted: December 8, 2006    Key Record Dates
Last Update Posted: November 23, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms