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Interstitial CystitisPhase 4NCT00086684

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

A Phase 4 study testing Pentosan polysulfate sodium 100 mg in people with Interstitial Cystitis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 65 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Interstitial Cystitis
What is being tested?
Pentosan polysulfate sodium 100 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
369 participants
Where
65 sitesin 2 countries
Study dates
Sep 2003to Jun 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

65 sites in 2 countries.

65 sites in 2 countries

United States52 sites

  • Study site

    Albany, New York

  • Study site

    Anchorage, Alaska

  • Study site

    Arlington, Texas

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Birmingham, Alabama

  • Study site

    Carrollton, Texas

  • Study site

    Celebration, Florida

  • Study site

    Centralia, Illinois

  • Study site

    Charlotte, North Carolina

  • Study site

    Concord, North Carolina

  • Study site

    Dearborn, Michigan

  • Study site

    Denver, Colorado

  • Study site

    Evanston, Illinois

  • Study site

    Fort Worth, Texas

  • Study site

    Grand Rapids, Michigan

  • Study site

    Henderson, Nevada

  • Study site

    Homewood, Alabama

  • Study site

    Jeffersonville, Indiana

  • Study site

    Kalamazoo, Michigan

  • Study site

    Lima, Ohio

  • Study site

    Longmont, Colorado

  • Study site

    Longwood, Florida

  • Study site

    Medford, Oregon

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Mountlake Terrace, Washington

  • Study site

    Nashville, Tennessee

  • Study site

    Newington, Connecticut

  • Study site

    Norwalk, Connecticut

  • Study site

    Ogden, Utah

  • Study site

    Peoria, Illinois

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Plantation, Florida

  • Study site

    Ponca City, Oklahoma

  • Study site

    Portland, Oregon

  • Study site

    Richmond, Virginia

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Bernardino, California

  • Study site

    San Carlos, California

  • Study site

    San Diego, California

  • Study site

    Seattle, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Tampa, Florida

  • Study site

    Torrance, California

  • Study site

    Trinity, Florida

  • Study site

    Tulsa, Oklahoma

  • Study site

    Venice, Florida

  • Study site

    West Orange, New Jersey

  • Study site

    Weston, Florida

  • Study site

    Wheat Ridge, Colorado

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

Canada13 sites

  • Study site

    Barrie, Ontario

  • Study site

    Burlington, Ontario

  • Study site

    Edmonton, Alberta

  • Study site

    Fredericton, New Brunswick

  • Study site

    Halifax, Nova Scotia

  • Study site

    Kelowna, British Columbia

  • Study site

    Kentville, Nova Scotia

  • Study site

    Kingston, Ontario

  • Study site

    Kitchener, Ontario

  • Study site

    Newmarket, Ontario

  • Study site

    Surrey, British Columbia

  • Study site

    Toronto, Ontario

  • Study site

    Victoria, British Columbia

Other trials in Canada

About this study

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

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.

Read the 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

Being tested
Pentosan polysulfate sodium 100 mg, Placebo
Keywords
Interstitial Cystitis, Urinary Bladder Pain
Medical subject headings
Cystitis, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pentosan polysulfate sodium 100 mgDrug

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

  • PlaceboDrug

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

  • Pentosan polysulfate sodium 100 mgDrug

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

Study groups in NCT00086684
Study groupRoleWhat they receive
Pentosan polysulfate sodium 100 mg once a dayExperimentalOne 100 mg pentosan polysulfate sodium capsule in the morning and 1 matching placebo capsule in the afternoon and evening for 24 weeks
Receives: Drug: Pentosan polysulfate sodium 100 mg
Pentosan polysulfate sodium 100 mg three times a dayExperimentalOne 100 mg pentosan polysulfate sodium capsule 3 times a day (morning afternoon and evening) for 24 weeks
Receives: Drug: Pentosan polysulfate sodium 100 mg
PlaceboPlacebo comparatorPlacebo One placebo capsule 3 times a day (morning afternoon and evening) for 24 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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.

    Measured: Baseline to Week 24

Secondary outcomes (1)

  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

    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.

    Measured: Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2004 (estimated)
  2. Study startSep 2003
  3. Primary completionJun 2011
  4. Study completionJun 2011

Why it stopped: Interim Analysis showed that study continuation was futile. No safety concerns were raised during the trial.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
369 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00086684
Sponsor's protocol ID
CR004576
Other IDs
C-2002-036
Status last verified
Apr 2014
First submitted
7 Jul 2004
Last updated
21 Apr 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 32734597

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pentosan polysulfate sodium 100 mg in people with Interstitial Cystitis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 65 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00086684, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.

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