An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00601484

Purpose

The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.

Condition	Intervention	Phase
Cystitis, Interstitial	Drug: PF-04383119 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, 16 Week, Multicenter, Randomized, Double Blind Placebo Controlled, Parallel Group Proof Of Concept Study Evaluating The Efficacy And Safety Of PF-04383119 For The Treatment Of Pain Associated With Interstitial Cystitis

Resource links provided by NLM:

MedlinePlus related topics: Interstitial Cystitis

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in average daily pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change in Pelvic Pain and Urgency/Frequency (PUF) symptom score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Global response assessment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Patient-reported treatment impact assessment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Treatment failures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Biomarkers [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Safety endpoints [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Pharmacokinetic measures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change in average daily pain [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change in micturition variables including frequency, nocturnal frequency, incontinence episode frequency, mean volume voided per micturition, mean interstitial cystitis pain severity, urinary urgency episodes, average sleep disturbance score,.... [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment:	65
Study Start Date:	March 2008
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: PF-04383119 PF-04383119 200 mcg/kg IV, single dose
2: Placebo Comparator	Drug: Placebo placebo IV, single dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female adults at least 18 years of age;
Moderate to severe interstitial cystitis, with a mean pain intensity score above a pre-defined level.

Exclusion Criteria:

Less than 6 months since onset of interstitial cystitis symptoms;
History of recurrent urinary tract infections, or genitourinary cancer;
History of hepatitis B, C or human immunodeficiency virus (HIV);
Use of certain drugs given into the bladder up to 1 month prior to study entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601484

Hide Study Locations

Locations

United States, Arizona
Pfizer Investigational Site
Peoria, Arizona, United States, 85381
United States, California
Pfizer Investigational Site
Fresno, California, United States, 93710
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
Glendora, California, United States, 91741
United States, Colorado
Pfizer Investigational Site
Boulder, Colorado, United States, 80304
United States, Connecticut
Pfizer Investigational Site
New Britain, Connecticut, United States, 06052
Pfizer Investigational Site
New London, Connecticut, United States, 06320
Pfizer Investigational Site
Hartford, Connecticut, United States, 06041
Pfizer Investigational Site
Hartford, Connecticut, United States, 06106
Pfizer Investigational Site
Middlebury, Connecticut, United States, 06762
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30308
United States, Indiana
Pfizer Investigational Site
Jeffersonville, Indiana, United States, 47130
United States, Louisiana
Pfizer Investigational Site
Shreveport, Louisiana, United States, 71106
United States, Maryland
Pfizer Investigational Site
Owings Mills, Maryland, United States, 21117
United States, Michigan
Pfizer Investigational Site
Royal Oak, Michigan, United States, 48073
Pfizer Investigational Site
Troy, Michigan, United States, 48084
Pfizer Investigational Site
Utica, Michigan, United States, 48313
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68114
United States, New York
Pfizer Investigational Site
Rochester, New York, United States, 14627
Pfizer Investigational Site
New Hyde Park, New York, United States, 11040
United States, North Carolina
Pfizer Investigational Site
Greensboro, North Carolina, United States, 27403
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45212
United States, Oklahoma
Pfizer Investigational Site
Bethany, Oklahoma, United States, 73008
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Pfizer Investigational Site
Greer, South Carolina, United States, 29650
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77024
United States, Washington
Pfizer Investigational Site
Spokane, Washington, United States, 99208
Pfizer Investigational Site
Mountlake, Washington, United States, 98043

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A4091010
Study First Received:	January 15, 2008
Last Updated:	May 18, 2009
ClinicalTrials.gov Identifier:	NCT00601484 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Painful Bladder Syndrome, monoclonal antibody

Additional relevant MeSH terms:

Cystitis, Interstitial
Urologic Diseases
Urinary Bladder Diseases
Cystitis

ClinicalTrials.gov processed this record on November 27, 2009