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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
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Description
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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 for the relief of bladder pain or discomfort associated with interstitial cystitis.

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Drug: Pentosan polysulfate sodium 100 mg Drug: Placebo Phase 4

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 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
Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
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
 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
 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
 Drug: Placebo
One placebo capsule 3 times a day (morning, afternoon and evening) for 24 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Interstitial Cystitis
Urinary Bladder Pain
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
 Urologic Diseases
Pentosan Sulfuric Polyester
Anticoagulants