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

November 12, 2010 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • 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
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Pfizer Investigational Site
      • Nijmegen, Netherlands, 6525 GA
        • Pfizer Investigational Site
  • Slovakia
      • 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
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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
Active Comparator: UK-369,003
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Duration of study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

December 6, 2006

First Submitted That Met QC Criteria

December 7, 2006

First Posted (Estimate)

December 8, 2006

Study Record Updates

Last Update Posted (Estimate)

November 23, 2010

Last Update Submitted That Met QC Criteria

November 12, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3711045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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