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
  Purpose

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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00408954     History of Changes
Other Study ID Numbers: A3711045
Study First Received: December 6, 2006
Last Updated: November 12, 2010
Health Authority: Slovakia: State Institute for Drug Control

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014