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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Cystitis, Interstitial

Treatments: Drug: PF-04383119; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00601484

IC POC (Other Identifier)

A4091010

Details and patient eligibility

About

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

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: PF-04383119

2

Placebo Comparator group

Treatment:

Drug: Placebo