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

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

This study is currently recruiting participants.
Information provided by Pfizer

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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

Brief Summary

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

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Cystitis, Interstitial
Painful Bladder Syndrome

Intervention ^†

Drug: PF-04383119
Drug: Placebo

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

March 2008

Completion Date

December 2008

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:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00601484

Organization ID

A4091010

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

June 2008

First Received Date ^†

January 15, 2008

Last Updated Date

June 10, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.