NCT00408954

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_2

Geographic Reach
3 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

November 23, 2010

Status Verified

November 1, 2010

Enrollment Period

1.3 years

First QC Date

December 6, 2006

Last Update Submit

November 12, 2010

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (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.

    Duration of study

Secondary Outcomes (14)

  • Maximum flow rate (Qmax)

    Duration of study

  • Cystometric capacity

    Duration of study

  • Post void residual volume (PVR)

    Duration of study

  • Average flow rate (Qave)

    Duration of study

  • Volume at first unstable contraction

    Duration of study

  • +9 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: UK-369,003

UK-369,003

ACTIVE COMPARATOR
Drug: UK-369,003

Interventions

UK-369,003DRUG

100 mg MR tablet once daily for 2 weeks

UK-369,003

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • prostate cancer
  • Post-void residual urine volume \>200 ml
  • Documented UTI
  • History of relevant urological surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Pfizer Investigational Site

Brno, 612 00, Czechia

Location

Pfizer Investigational Site

Hradec Králové, 500 02, Czechia

Location

Pfizer Investigational Site

Olomouc, 775 20, Czechia

Location

Pfizer Investigational Site

Ústí nad Labem, 401 13, Czechia

Location

Pfizer Investigational Site

Amsterdam, 1081 HV, Netherlands

Location

Pfizer Investigational Site

Nijmegen, 6525 GA, Netherlands

Location

Pfizer Investigational Site

Bratislava, Slovakia, 833 05, Slovakia

Location

Pfizer Investigational Site

Martin, Slovakia, 036 59, Slovakia

Location

Pfizer Investigational Site

Trenčín, Slovakia, 911 01, Slovakia

Location

Pfizer Investigational Site

Košice, 040 11, Slovakia

Location

Pfizer Investigational Site

Košice, 041 90, Slovakia

Location

Related Links

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

1-(6-ethoxy-5-(3-ethyl-6,7-dihydro-2-(2-methoxyethyl)-7-oxo-2H-pyrazolo(4,3-d)pyrimidin-5-yl)-3-pyridyl sulphonyl)-4-ethylpiperazine

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 6, 2006

First Posted

December 8, 2006

Study Start

March 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

November 23, 2010

Record last verified: 2010-11

Locations

CZ(4)NL(2)SL(5)