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

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 Painful Bladder Syndrome	Drug: PF-04383119 Drug: Placebo	Phase II

MedlinePlus related topics:

Interstitial Cystitis

U.S. FDA Resources

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

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 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 ]
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 O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
2: Placebo Comparator	Drug: Placebo placebo IV, single dose
1: Experimental	Drug: PF-04383119 PF-04383119 200 mcg/kg 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 genito-urinary cancer
History of hepatitis B, C or human immunodeficiency virus (HIV)
Previous treatment with an implanted peripheral nerve stimulator
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

Contacts


Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations


United States, Arizona
	Pfizer Investigational Site	Not yet recruiting
	Peoria, Arizona, United States, 85381

United States, California
	Pfizer Investigational Site	Recruiting
	Fresno, California, United States, 93710

United States, Colorado
	Pfizer Investigational Site	Not yet recruiting
	Boulder, Colorado, United States, 80304

United States, Connecticut
	Pfizer Investigational Site	Not yet recruiting
	Hartford, Connecticut, United States, 06041
	Pfizer Investigational Site	Not yet recruiting
	Hartford, Connecticut, United States, 06106
	Pfizer Investigational Site	Not yet recruiting
	Middlebury, Connecticut, United States, 06762

United States, Georgia
	Pfizer Investigational Site	Not yet recruiting
	Atlanta, Georgia, United States, 30308

United States, Indiana
	Pfizer Investigational Site	Recruiting
	Jeffersonville, Indiana, United States, 47130

United States, Louisiana
	Pfizer Investigational Site	Recruiting
	Shreveport, Louisiana, United States, 71106

United States, Maryland
	Pfizer Investigational Site	Not yet recruiting
	Owings Mills, Maryland, United States, 21117

United States, Michigan
	Pfizer Investigational Site	Recruiting
	Royal Oak, Michigan, United States, 48073

United States, Nebraska
	Pfizer Investigational Site	Recruiting
	Omaha, Nebraska, United States, 68114

United States, North Carolina
	Pfizer Investigational Site	Not yet recruiting
	Greensboro, North Carolina, United States, 27403

United States, Ohio
	Pfizer Investigational Site	Not yet recruiting
	Cincinnati, Ohio, United States, 45212

United States, Pennsylvania
	Pfizer Investigational Site	Not yet recruiting
	Pittsburgh, Pennsylvania, United States, 15212

United States, South Carolina
	Pfizer Investigational Site	Recruiting
	Greer, South Carolina, United States, 29650

United States, Texas
	Pfizer Investigational Site	Recruiting
	Houston, Texas, United States, 77024

United States, Washington
	Pfizer Investigational Site	Recruiting
	Spokane, Washington, United States, 99207

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A4091010
First Received:	January 15, 2008
Last Updated:	April 22, 2008
ClinicalTrials.gov Identifier:	NCT00601484
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cystitis, Interstitial

Pregnancy Complications

Urologic Diseases

Urinary Bladder Diseases

Cystitis

Pain

Additional relevant MeSH terms:

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Female Urogenital Diseases

ClinicalTrials.gov processed this record on May 08, 2008

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