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

Primary Purpose

Interstitial Cystitis

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Pentosan polysulfate sodium 100 mg
Placebo
Pentosan polysulfate sodium 100 mg
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial Cystitis, Urinary Bladder Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Pentosan polysulfate sodium 100 mg once a day

Pentosan polysulfate sodium 100 mg three times a day

Placebo

Arm Description

One 100 mg pentosan polysulfate sodium capsule in the morning and 1 matching placebo capsule in the afternoon and evening for 24 weeks

One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning afternoon and evening) for 24 weeks

Placebo One placebo capsule 3 times a day (morning afternoon and evening) for 24 weeks

Outcomes

Primary Outcome Measures

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
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

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
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.

Full Information

First Posted
July 7, 2004
Last Updated
April 2, 2014
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT00086684
Brief Title
Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis
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 Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Interim Analysis showed that study continuation was futile. No safety concerns were raised during the trial.
Study Start Date
September 2003 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis
Keywords
Interstitial Cystitis, Urinary Bladder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
369 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pentosan polysulfate sodium 100 mg once a day
Arm Type
Experimental
Arm Description
One 100 mg pentosan polysulfate sodium capsule in the morning and 1 matching placebo capsule in the afternoon and evening for 24 weeks
Arm Title
Pentosan polysulfate sodium 100 mg three times a day
Arm Type
Experimental
Arm Description
One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning afternoon and evening) for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo One placebo capsule 3 times a day (morning afternoon and evening) for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Pentosan polysulfate sodium 100 mg
Intervention Description
One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning, afternoon, and evening) for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One placebo capsule 3 times a day (morning, afternoon and evening) for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Pentosan polysulfate sodium 100 mg
Intervention Description
One 100 mg pentosan polysulfate sodium capsule in the morning, and 1 matching placebo capsule in the afternoon and evening for 24 weeks
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
City
Birmingham
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Alabama
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United States
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Homewood
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Alabama
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Anchorage
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Alaska
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San Bernardino
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San Carlos
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San Diego
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Torrance
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Denver
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Longmont
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Colorado
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Wheat Ridge
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Colorado
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Newington
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Norwalk
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Celebration
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Longwood
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Plantation
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Tampa
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Trinity
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Venice
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Weston
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Atlanta
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Centralia
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Evanston
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Peoria
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Jeffersonville
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Dearborn
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Grand Rapids
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Kalamazoo
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Saint Louis
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Henderson
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West Orange
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New Jersey
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Albany
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New York
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Charlotte
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North Carolina
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Concord
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Winston Salem
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Lima
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Ponca City
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Tulsa
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Medford
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Portland
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Philadelphia
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Nashville
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Arlington
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Austin
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Carrollton
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Fort Worth
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San Antonio
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Ogden
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Utah
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Salt Lake City
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Richmond
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Virginia
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Mountlake Terrace
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Seattle
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Milwaukee
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Wisconsin
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Edmonton
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Alberta
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Canada
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Kelowna
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British Columbia
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Canada
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Surrey
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British Columbia
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Canada
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Victoria
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British Columbia
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Canada
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Fredericton
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New Brunswick
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Canada
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Halifax
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Nova Scotia
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Canada
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Kentville
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Canada
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Barrie
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Ontario
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Burlington
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Kingston
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Ontario
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Kitchener
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Newmarket
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Toronto
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Ontario
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Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
32734597
Citation
Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
Results Reference
derived

Learn more about this trial

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

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