Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis

The purpose of this multi-center, double-blind (neither the patient nor the physician knows
whether drug or placebo is being taken, or at what dosage), randomized (patients are
assigned different treatments based on chance), parallel group trial is to evaluate the
effectiveness and safety of two doses of pentosan polysulfate sodium (100 mg once a day and
100 mg three times a day) versus placebo for 24 weeks for the relief of bladder pain or
discomfort associated with interstitial cystitis. The hypothesis of the study is that there
is no treatment difference in the proportion of responders at study endpoint (Week 24).
Effectiveness will be assessed based on the reduction in the O'Leary-Sant Interstitial
Cystitis Symptom Index (ICSI) total score. Safety assessments include vital signs,
laboratory tests, adverse events and physical exams. Patients will receive one of the
following study treatments by mouth each day for 24 weeks: pentosan polysulfate sodium 100
mg once a day group - one pentosan polysulfate sodium 100 mg capsule in the morning, and one
matching placebo capsule in the afternoon and evening; pentosan polysulfate sodium 100 mg
capsule three times a day group - one pentosan polysulfate sodium 100 mg capsule in the
morning, afternoon and evening; placebo group - one placebo capsule in the morning,
afternoon and evening