Trial Information

Summary: Primary objective of this study is to evaluate the efficacy, safety and tolerability of an investigational drug in the treatment of pain associated with Interstitial Cystitis also known as Painful Bladder

This is an 18 week study (7 clinic visits) in the treatment of pain associated with interstitial cystitis as well as other symptoms, such as having to urinate often, and feeling a strong urge to urinate which is difficult to ignore. Since this drug is still being tested, your participation in this study will provide information to help evaluate the safety, tolerability and pharmacokinetics (how the drug is absorbed and broken down by the body) of PF-04383119 when given to patients with interstitial cystitis.

Inclusion Criteria:

• Male or female at least 18 years of age
• Moderate to severe interstitial cystitis
• Women of childbearing potential must have a negative urine pregnancy test or be post menopausal for at least 1 year, or had a hysterectomy and/or bilateral oophorectomy
• Be able to read and willing to complete subject diaries and questionnaires throughout the study

Exclusion Criteria:

• Subjects with symptoms of interstitial cystitis less than 6 months
• History or signs and symptoms of clinically significant cardiac disease
• History of clinically significant neurological disease including but not limited to stroke or TIA, alzheimer’s disease or other types of dementia, head trauma, and epilepsy or seizure
• Subjects who within the last 3 months had bacterial cystitis, bacterial prostatitis, infective urethritis or active genital herpes
• Hospitalized for Anxiety Depression
• Positive Hepatitis B, Hepatitis C
• Subjects with history of alcohol or drug abuse tin past 2 years
• Subjects with indwelling urinary catheters or who perform Intermittent Self Catheterization

Additional inclusion and exclusion criteria apply and will be reviewed with you.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.