Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 October 2017 |
Main ID: |
NCT00086684 |
Date of registration:
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07/07/2004 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis
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Scientific title:
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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 |
Date of first enrolment:
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September 2003 |
Target sample size:
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369 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT00086684 |
Study type:
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Interventional |
Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial |
Address:
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Telephone:
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Email:
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Affiliation:
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Interstitial Cystitis
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Intervention(s)
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Drug: Placebo
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Drug: Pentosan polysulfate sodium 100 mg
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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C-2002-036
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CR004576
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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