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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Interstitial Cystitis

In brief

The purpose of this study is to evaluate the safety and effectiveness of pentosan polysulfate sodium 100 mg once a day, pentosan polysulfate sodium 100 mg three times a day, and placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis.

Key facts

Study ID

NCT00086684

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

369

Starts

2003-09-01

Expected to finish

2011-06-01

Last updated by the study team

2014-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Homewood, Alabama, United States
• Study site — Anchorage, Alaska, United States
• Study site — San Bernardino, California, United States
• Study site — San Carlos, California, United States
• Study site — San Diego, California, United States
• Study site — Torrance, California, United States
• Study site — Denver, Colorado, United States
• Study site — Longmont, Colorado, United States
• Study site — Wheat Ridge, Colorado, United States
• Study site — Newington, Connecticut, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Celebration, Florida, United States
• Study site — Longwood, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Trinity, Florida, United States
• Study site — Venice, Florida, United States
• Study site — Weston, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Centralia, Illinois, United States
• Study site — Evanston, Illinois, United States
• Study site — Peoria, Illinois, United States
• Study site — Jeffersonville, Indiana, United States
• Study site — Dearborn, Michigan, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.