Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis
Interstitial Cystitis
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial Cystitis, Urinary Bladder Pain
Eligibility Criteria
Inclusion Criteria: Must have a total score of 8 or greater on the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) and a score of > 0 on each of the 4 questions on the ICSI must have experienced bladder pain, urinary urgency and urinary frequency, each not related to a urinary tract infection, for at least 6 months prior to entry into the study must have averaged >= 10 voids per day (>=30 voids over 3 consecutive days) and averaged >= 1 void at night urine culture showing no evidence of urinary tract infection urine cytology showing no evidence of neoplastic cells Exclusion Criteria: Scheduled for or use of intravesical therapy (eg, bladder distention, dimethyl sulfoxide) during or within 4 weeks prior to the study patients who have had cytoscopic evaluation within 4 weeks prior to the study patients who are currently (within last month) receiving other medications that may affect symptoms of interstitial cystitis (ie, antidepressants, antihistamines, antispasmodics, anticholinergics) patients who are chronic users of Schedule II narcotics or who are using any scheduled narcotics at the time of study entry patients taking coumadin, anticoagulants, heparin, or thrombolytic agents such as tissue plasminogen activator and streptokinase
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Pentosan polysulfate sodium 100 mg once a day
Pentosan polysulfate sodium 100 mg three times a day
Placebo
One 100 mg pentosan polysulfate sodium capsule in the morning and 1 matching placebo capsule in the afternoon and evening for 24 weeks
One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning afternoon and evening) for 24 weeks
Placebo One placebo capsule 3 times a day (morning afternoon and evening) for 24 weeks