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

Primary Purpose

Prostatic Hyperplasia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
UK-369,003
UK-369,003
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

UK-369,003

Arm Description

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 6, 2006
Last Updated
November 12, 2010
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00408954
Brief Title
Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms
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 Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
UK-369,003
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
UK-369,003
Intervention Description
100 mg MR tablet once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
UK-369,003
Intervention Description
UK-369,003-100 mg MR formulation for 2 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Maximum flow rate (Qmax)
Time Frame
Duration of study
Title
Cystometric capacity
Time Frame
Duration of study
Title
Post void residual volume (PVR)
Time Frame
Duration of study
Title
Average flow rate (Qave)
Time Frame
Duration of study
Title
Volume at first unstable contraction
Time Frame
Duration of study
Title
Average detrusor pressure during micturition
Time Frame
Duration of study
Title
Detrusor pressure at maximum flow rate (PdetQmax)
Time Frame
Duration of study
Title
Bladder outlet obstruction index (BOOI)
Time Frame
Duration of study
Title
Bladder contractility index (BCI)
Time Frame
Duration of study
Title
Bladder voiding efficiency (BE)
Time Frame
Duration of study
Title
Frequency of unstable contractions
Time Frame
Duration of study
Title
International Prostate Symptom Score (IPSS)
Time Frame
Duration of study
Title
Mean amplitude of unstable contractions
Time Frame
Duration of study
Title
Patient Reported Treatment Impact (PRTI)
Time Frame
Duration of study

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Brno
ZIP/Postal Code
612 00
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 02
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
833 05
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Kosice
ZIP/Postal Code
040 11
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Kosice
ZIP/Postal Code
041 90
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3711045&StudyName=Urodynamic%20effects%20of%20UK-369%2C003%20in%20men%20with%20lower%20urinary%20tract%20symptoms.
Description
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Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms

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