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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00408954

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia	Drug: UK-369,003 Drug: UK-369,003	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, 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.

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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. [Duration of study]

Secondary Outcome Measures

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]
Average detrusor pressure during micturition [Duration of study]
Detrusor pressure at maximum flow rate (PdetQmax) [Duration of study]
Bladder outlet obstruction index (BOOI) [Duration of study]
Bladder contractility index (BCI) [Duration of study]
Bladder voiding efficiency (BE) [Duration of study]
Frequency of unstable contractions [Duration of study]
International Prostate Symptom Score (IPSS) [Duration of study]
Mean amplitude of unstable contractions [Duration of study]
Patient Reported Treatment Impact (PRTI) [Duration of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Pfizer Investigational Site	Brno	Czech Republic	612 00
2	Pfizer Investigational Site	Hradec Kralove	Czech Republic	500 02
3	Pfizer Investigational Site	Olomouc	Czech Republic	775 20
4	Pfizer Investigational Site	Usti nad Labem	Czech Republic	401 13
5	Pfizer Investigational Site	Amsterdam	Netherlands	1081 HV
6	Pfizer Investigational Site	Nijmegen	Netherlands	6525 GA
7	Pfizer Investigational Site	Bratislava	Slovakia	833 05
8	Pfizer Investigational Site	Kosice	Slovakia	040 11
9	Pfizer Investigational Site	Kosice	Slovakia	041 90
10	Pfizer Investigational Site	Martin	Slovakia	036 59
11	Pfizer Investigational Site	Trencin	Slovakia	911 01

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00408954

Other Study ID Numbers:

A3711045

First Posted:

Dec 8, 2006

Last Update Posted:

Nov 23, 2010

Last Verified:

Nov 1, 2010

Additional relevant MeSH terms:

Prostatic Hyperplasia

Hyperplasia

Lower Urinary Tract Symptoms

Study Results

No Results Posted as of Nov 23, 2010