Status:
TERMINATED
Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Interstitial Cystitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 f...
Detailed Description
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 trea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT00086684
Start Date
September 1 2003
End Date
June 1 2011
Last Update
April 21 2014
Active Locations (65)
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1
Birmingham, Alabama, United States
2
Homewood, Alabama, United States
3
Anchorage, Alaska, United States
4
San Bernardino, California, United States