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 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 ]
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
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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

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

Contacts


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

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:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00601484
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cystitis, Interstitial

Urinary Bladder Diseases

Cystitis

Pain

Additional relevant MeSH terms:

Pathologic Processes

Disease

Urologic Diseases

Syndrome

ClinicalTrials.gov processed this record on July 03, 2008

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