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

NCT ID: NCT00408954

Last Updated: 2010-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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Conditions

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Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

UK-369,003

Intervention Type DRUG

UK-369,003-100 mg MR formulation for 2 weeks

UK-369,003

Group Type ACTIVE_COMPARATOR

UK-369,003

Intervention Type DRUG

100 mg MR tablet once daily for 2 weeks

Interventions

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UK-369,003

100 mg MR tablet once daily for 2 weeks

Intervention Type DRUG

UK-369,003

UK-369,003-100 mg MR formulation for 2 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brno, , Czechia

Site Status

Pfizer Investigational Site

Hradec Králové, , Czechia

Site Status

Pfizer Investigational Site

Olomouc, , Czechia

Site Status

Pfizer Investigational Site

Ústí nad Labem, , Czechia

Site Status

Pfizer Investigational Site

Amsterdam, , Netherlands

Site Status

Pfizer Investigational Site

Nijmegen, , Netherlands

Site Status

Pfizer Investigational Site

Bratislava, Slovakia, Slovakia

Site Status

Pfizer Investigational Site

Martin, Slovakia, Slovakia

Site Status

Pfizer Investigational Site

Trenčín, Slovakia, Slovakia

Site Status

Pfizer Investigational Site

Košice, , Slovakia

Site Status

Pfizer Investigational Site

Košice, , Slovakia

Site Status

Countries

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Czechia Netherlands Slovakia

Related Links

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Other Identifiers

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A3711045

Identifier Type: -

Identifier Source: org_study_id