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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.
COMPENSATION: Eligible patients will receive up to $400.00
STUDY DESCRIPTION: 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 more information, or to see if you qualify for this study,
please contact study coordinators:
Carolyn Eustace, RA
Karen Cuddy, RN
(860) 443-4567
or contact us by e-mail at
CCRvolunteer@gmail.com
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