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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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
Experimental: 1	Drug: PF-04383119 PF-04383119 200 mcg/kg IV, single dose
Placebo Comparator: 2	Drug: Placebo placebo IV, single dose

Eligibility

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:

Contacts and Locations

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00601484 History of Changes
Other Study ID Numbers:	A4091010
Study First Received:	January 15, 2008
Last Updated:	January 4, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Painful Bladder Syndrome, monoclonal antibody

Additional relevant MeSH terms:

Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on February 12, 2012