Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis
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ClinicalTrials.gov Identifier: NCT00086684 |
Recruitment Status :
Terminated
(Interim Analysis showed that study continuation was futile. No safety concerns were raised during the trial.)
First Posted : July 9, 2004
Results First Posted : July 6, 2012
Last Update Posted : April 21, 2014
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Condition or disease | Intervention/treatment | Phase |
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Interstitial Cystitis | Drug: Pentosan polysulfate sodium 100 mg Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 369 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Randomized, Double-Blind, Placebo-Controlled, Parallel Group Evaluation of the Efficacy and Tolerability of Two Different Doses of ELMIRON for the Treatment of Interstitial Cystitis |
Study Start Date : | September 2003 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
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Experimental: Pentosan polysulfate sodium 100 mg once a day
One 100 mg pentosan polysulfate sodium capsule in the morning and 1 matching placebo capsule in the afternoon and evening for 24 weeks
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Drug: Pentosan polysulfate sodium 100 mg
One 100 mg pentosan polysulfate sodium capsule in the morning, and 1 matching placebo capsule in the afternoon and evening for 24 weeks |
Experimental: Pentosan polysulfate sodium 100 mg three times a day
One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning afternoon and evening) for 24 weeks
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Drug: Pentosan polysulfate sodium 100 mg
One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning, afternoon, and evening) for 24 weeks |
Placebo Comparator: Placebo
Placebo One placebo capsule 3 times a day (morning afternoon and evening) for 24 weeks
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Drug: Placebo
One placebo capsule 3 times a day (morning, afternoon and evening) for 24 weeks |
- Number of Responders Defined as Having at Least a 30% Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint [ Time Frame: Baseline to Week 24 ]The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition.
- Number of Responders Defined as Having at Least a Four Point Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint [ Time Frame: Baseline to Week 24 ]The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086684

Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00086684 |
Obsolete Identifiers: | NCT00399139 |
Other Study ID Numbers: |
CR004576 C-2002-036 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ) |
First Posted: | July 9, 2004 Key Record Dates |
Results First Posted: | July 6, 2012 |
Last Update Posted: | April 21, 2014 |
Last Verified: | April 2014 |
Interstitial Cystitis Urinary Bladder Pain |
Cystitis Cystitis, Interstitial Urinary Bladder Diseases |
Urologic Diseases Pentosan Sulfuric Polyester Anticoagulants |